Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analy...
Diagnostic Devices·4,895 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of a...
Diagnostic Devices·2,001 affected·Mar 10, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a ...
Diagnostic Devices·1,148 affected·Mar 10, 2023
High RiskFDA
Philips North America Llc
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Diagnostic Devices·10 affected·Mar 9, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Diagnostic Devices·10 affected·Mar 9, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Ve...
Diagnostic Devices·256 affected·Mar 9, 2023
High RiskFDA
Philips North America
ProxiDiagnost N90 R.1.0
Diagnostic Devices·25 affected·Mar 3, 2023
High RiskFDA
Philips North America
CombiDiagnost R90 R.1.0
Diagnostic Devices·25 affected·Mar 3, 2023
High RiskFDA
Philips North America
CombiDiagnost R90 R1.1
Diagnostic Devices·25 affected·Mar 3, 2023
High RiskFDA
Bio-rad Laboratories, Inc.
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Diagnostic Devices·932 affected·Feb 28, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Ex...
Diagnostic Devices·397 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room tempe...
Diagnostic Devices·97 affected·Feb 21, 2023
High RiskFDA
Unetixs Vascular, Inc.
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Diagnostic Devices·2,000 affected·Feb 10, 2023
High RiskFDA
Unetixs Vascular, Inc.
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Diagnostic Devices·1,706 affected·Feb 10, 2023
High RiskFDA
Sedecal Sa
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Diagnostic Devices·7 affected·Feb 6, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane...
Diagnostic Devices·141 affected·Feb 2, 2023
High RiskFDA
Biofire Diagnostics, Llc
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Diagnostic Devices·2 affected·Feb 1, 2023
High RiskFDA
Carestream Health, Inc.
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to a...
Diagnostic Devices·72 affected·Jan 30, 2023
High RiskFDA
Diasorin Molecular Llc
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Diagnostic Devices·90,142 affected·Jan 30, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plas...
Diagnostic Devices·11,824 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (li...
Diagnostic Devices·8,420 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithi...
Diagnostic Devices·13,071 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithiu...
Diagnostic Devices·5,315 affected·Jan 27, 2023
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Diagnostic Devices·4 affected·Jan 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cel...
Diagnostic Devices·13,843 affected·Jan 9, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red bloo...
Diagnostic Devices·1,865 affected·Jan 9, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies...
Diagnostic Devices·158 affected·Dec 22, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Diagnostic Devices·2 affected·Dec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Diagnostic Devices·28 affected·Dec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Diagnostic Devices·7 affected·Dec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Diagnostic Devices·4 affected·Dec 21, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Diagnostic Devices·1 affected·Dec 21, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi...
Diagnostic Devices·717 affected·Dec 7, 2022
High RiskFDA
Future Diagnostics Solutions B.v.
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Diagnostic Devices·342 affected·Dec 6, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu...
Diagnostic Devices·115 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems ...
Diagnostic Devices·146 affected·Nov 22, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Programmable Diagnostic Computer
Diagnostic Devices·2,213 affected·Nov 16, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Diagnostic Devices·15 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Diagnostic Devices·64 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
Diagnostic Devices·13 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Diagnostic Devices·50 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Diagnostic Devices·13 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
Diagnostic Devices·26 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
Diagnostic Devices·310 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
Diagnostic Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
Diagnostic Devices·34 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
Diagnostic Devices·218 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
Diagnostic Devices·2 affected·Nov 9, 2022