Becton Dickinson & Co.
66 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Becton Dickinson & Co. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-10FDA-DeviceClass IIBD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for yeast identification.
Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected. Esculin is expected to trigger this fluorescence and test cancellation.
- 2024-04-10FDA-DeviceClass IIBD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- 2024-02-14FDA-DeviceClass IIBD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
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