Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIAIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceC.R. Bard, Inc.Class IIBardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Foley Catheter with Incorrect Retainer Cap Print
- 2018-06-13FDA-DeviceOrthofix SrlClass IITL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segme
The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.
- 2018-06-13FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
- 2018-06-13FDA-DeviceNordicNeuroLab ASClass IInordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging da
The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration.
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