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.
- 2025-10-29FDA-DeviceClass IIBD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceClass IIBD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceClass IIBD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceClass IIBD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceClass IIBD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-10-29FDA-DeviceClass IIBD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2025-07-30FDA-DeviceClass IIBD COR System Software. Model Number: 444829.
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
- 2025-07-02FDA-DeviceClass IIBD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
- 2025-03-12FDA-DeviceClass IIBD BBL TB Stain Kit K, Catalog (REF): 212522
One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
- 2025-01-29FDA-DeviceClass IIBD PCR Cartridges used with MAX System. Model Number: 437519
Potential for signal drift in specific lots of BD PCR Cartridges.
- 2024-12-11FDA-DeviceClass IIBD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
- 2024-12-11FDA-DeviceClass IIBACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-12-11FDA-DeviceClass IIBD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
- 2024-10-16FDA-DeviceClass IIBD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy
- 2024-10-02FDA-DeviceClass IIBD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
- 2024-10-02FDA-DeviceClass IIBD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
- 2024-08-28FDA-DeviceClass IIBD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
- 2024-08-21FDA-DeviceClass IIBD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
- 2024-06-12FDA-DeviceClass IIBD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
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