Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Biomerieux Inc
GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
Diagnostic Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
Diagnostic Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Diagnostic Devices·39 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
Diagnostic Devices·187 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
API NIT1 NIT2 REAGENTS, CATALOG 70442
Diagnostic Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
Diagnostic Devices·58 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
Diagnostic Devices·120 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
Diagnostic Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
Diagnostic Devices·46 affected·Nov 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diag...
Diagnostic Devices·1,000 affected·Nov 4, 2022
High RiskFDA
Randox Laboratories Ltd.
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Diagnostic Devices·20 affected·Nov 1, 2022
High RiskFDA
Randox Laboratories Ltd.
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Diagnostic Devices·20 affected·Nov 1, 2022
High RiskFDA
Cytocell Ltd.
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Diagnostic Devices·3 affected·Oct 27, 2022
High RiskFDA
Greer Laboratories, Inc.
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for dem...
Diagnostic Devices·218 affected·Oct 25, 2022
High RiskFDA
Philips North America Llc
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoro...
Diagnostic Devices·234 affected·Oct 21, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 ....
Diagnostic Devices·17,396 affected·Oct 13, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Diagnostic Devices·883 affected·Oct 12, 2022
High RiskFDA
Kamiya Biomedical Company, Llc
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Diagnostic Devices·165 affected·Sep 28, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Diagnostic Devices·586 affected·Sep 19, 2022
High RiskFDA
Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
Diagnostic Devices·5,141 affected·Sep 14, 2022
High RiskFDA
Luminostics, Inc Dba Clip Health
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Diagnostic Devices·10,037 affected·Sep 2, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalo...
Diagnostic Devices·1,592 affected·Aug 24, 2022
High RiskFDA
Gs Biomark Llc
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 ...
Diagnostic Devices·639,200 affected·Aug 8, 2022
High RiskFDA
Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Diagnostic Devices·2,451 affected·Jul 26, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material...
Diagnostic Devices·129 affected·Jul 18, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e801 Immunoassay Analyzer
Diagnostic Devices·965 affected·Jul 14, 2022
High RiskFDA
Luminex Corporation
ARIES SARS-CoV-2 Assay
Diagnostic Devices·257 affected·Jul 14, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin...
Diagnostic Devices·1,614 affected·Jun 28, 2022
High RiskFDA
Abbott Laboratories
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Diagnostic Devices·64 affected·Jun 9, 2022
High RiskFDA
Abbott Laboratories
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Diagnostic Devices·7,391 affected·Jun 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagu...
Diagnostic Devices·263 affected·Jun 1, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No...
Diagnostic Devices·27 affected·May 25, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
Diagnostic Devices·28 affected·May 25, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEA...
Diagnostic Devices·11 affected·May 25, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 T...
Diagnostic Devices·81 affected·May 25, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 2...
Diagnostic Devices·20 affected·May 25, 2022
CriticalFDA
American Contract Systems, Inc.
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Diagnostic Devices·274,400 affected·May 2, 2022
High RiskFDA
Haemonetics Corporation
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Diagnostic Devices·3,933 affected·Apr 26, 2022
High RiskFDA
Bio-rad Laboratories, Inc.
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Diagnostic Devices·348 affected·Apr 14, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens...
Diagnostic Devices·1,566 affected·Apr 13, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens ...
Diagnostic Devices·2,321 affected·Apr 13, 2022
CriticalFDA
Woodside Acquisitions Inc.
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Diagnostic Devices·17,000 affected·Apr 9, 2022
CriticalFDA
Woodside Acquisitions Inc.
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Diagnostic Devices·34,240 affected·Apr 9, 2022
High RiskFDA
Usa Medical, Llc
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Diagnostic Devices·2,055 affected·Apr 4, 2022
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa li...
Diagnostic Devices·199 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Diagnostic Devices·1,575 affected·Mar 25, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Diagnostic Devices·2,502 affected·Mar 25, 2022
High RiskFDA
Hologic, Inc
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Diagnostic Devices·2,061 affected·Mar 18, 2022