Category

Diagnostic Devices Recalls

1,863 diagnostic devices recalls on record from CPSC, FDA, and USDA.

1,863 recalls
High RiskFDA
Becton Dickinson & Company
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, t...
Diagnostic Devices·0 affected·Apr 11, 2018
High RiskFDA
Biomerieux Sa
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family...
Diagnostic Devices·59 affected·Apr 9, 2018
High RiskFDA
Visaris Doo
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of dia...
Diagnostic Devices·8 affected·Apr 5, 2018
High RiskFDA
Visaris Doo
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of dia...
Diagnostic Devices·8 affected·Apr 5, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for i...
Diagnostic Devices·35 affected·Apr 3, 2018
High RiskFDA
Immuno-mycologics, Inc
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatograp...
Diagnostic Devices·875 affected·Mar 30, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Diagnostic Devices·0 affected·Mar 27, 2018
High RiskFDA
Philips Medical Systems Nederlands
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, Gen...
Diagnostic Devices·199 affected·Mar 26, 2018
High RiskFDA
Philips Medical Systems Nederlands
708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography ca...
Diagnostic Devices·20 affected·Mar 26, 2018
High RiskFDA
Philips Medical Systems Nederlands
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiog...
Diagnostic Devices·37 affected·Mar 26, 2018
High RiskFDA
Philips Medical Systems Nederlands
MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, R...
Diagnostic Devices·1 affected·Mar 26, 2018
High RiskFDA
Biomerieux Sa
The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated ident...
Diagnostic Devices·135 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma...
Diagnostic Devices·2 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most ...
Diagnostic Devices·15 affected·Mar 23, 2018
High RiskFDA
Hycor Biomedical Inc
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF as...
Diagnostic Devices·288 affected·Mar 19, 2018
High RiskFDA
Philips Electronics North America Corporation
T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic imag...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Mul...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic ima...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, sp...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectrosc...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Biocare Medical, Llc
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: ...
Diagnostic Devices·11 affected·Mar 15, 2018
High RiskFDA
Accelerate Diagnostics Inc
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro ...
Diagnostic Devices·95 affected·Mar 14, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Diagnostic Devices·10,913 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Diagnostic Devices·4,027 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Diagnostic Devices·4,867 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Diagnostic Devices·4,824 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
Diagnostic Devices·24,410 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
Diagnostic Devices·12,614 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
Diagnostic Devices·2,867 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
Diagnostic Devices·9,033 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing qual...
Diagnostic Devices·2,864 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Diagnostic Devices·41,105 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Diagnostic Devices·14,690 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Diagnostic Devices·15,942 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Diagnostic Devices·5,990 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
Diagnostic Devices·12,361 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
Diagnostic Devices·10,023 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
Diagnostic Devices·1,442 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
Diagnostic Devices·43,275 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
Diagnostic Devices·1,047 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
Diagnostic Devices·5,491 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
Diagnostic Devices·752 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Diagnostic Devices·3,254 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Diagnostic Devices·49 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calib...
Diagnostic Devices·1,485 affected·Mar 5, 2018
High RiskFDA
Biomerieux, Inc.
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family ...
Diagnostic Devices·5,429 affected·Mar 1, 2018