Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immun...
Diagnostic Devices·95,453 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Fa...
Diagnostic Devices·418,400 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access ...
Diagnostic Devices·123,324 affected·Apr 30, 2019
RecallFDA
Abbott Laboratories
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum t...
Diagnostic Devices·1 affected·Apr 9, 2019
RecallFDA
Abbott Laboratories
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum t...
Diagnostic Devices·1 affected·Apr 9, 2019
CriticalFDA
Abbott Gmbh & Co. Kg
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CAB...
Diagnostic Devices·373 affected·Apr 5, 2019
High RiskFDA
Becton Dickinson & Co.
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
Diagnostic Devices·124 affected·Apr 3, 2019
High RiskFDA
Philips Medical Systems Nederlands
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for ...
Diagnostic Devices·4 affected·Mar 25, 2019
High RiskFDA
Opgen Inc
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic T...
Diagnostic Devices·80 affected·Mar 18, 2019
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer
Diagnostic Devices·149 affected·Mar 15, 2019
High RiskFDA
Biomerieux, Inc.
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the ide...
Diagnostic Devices·10,784 affected·Mar 15, 2019
RecallFDA
Cytocell Ltd.
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Diagnostic Devices·19 affected·Mar 15, 2019
High RiskFDA
Ge Healthcare, Llc
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiov...
Diagnostic Devices·22 affected·Mar 15, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is inte...
Diagnostic Devices·80 affected·Mar 11, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood cult...
Diagnostic Devices·20,350 affected·Mar 7, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solutio...
Diagnostic Devices·1,557 affected·Mar 7, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage...
Diagnostic Devices·17,188 affected·Mar 6, 2019
High RiskFDA
Topcon Medical Systems, Inc.
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and manag...
Diagnostic Devices·450 affected·Mar 6, 2019
High RiskFDA
Philips North America, Llc
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, univ...
Diagnostic Devices·1,696 affected·Feb 28, 2019
High RiskFDA
Philips North America, Llc
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ra...
Diagnostic Devices·1,969 affected·Feb 28, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer a...
Diagnostic Devices·559 affected·Feb 26, 2019
High RiskFDA
Abbott Laboratories
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic us...
Diagnostic Devices·6,353 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitativ...
Diagnostic Devices·267 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualita...
Diagnostic Devices·45 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·55 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, sem...
Diagnostic Devices·4 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qu...
Diagnostic Devices·25 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·62 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Philips Medical Systems Nederlands
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Serie...
Diagnostic Devices·7,209 affected·Feb 19, 2019
High RiskFDA
The Binding Site Group, Ltd.
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determ...
Diagnostic Devices·10 affected·Feb 19, 2019
High RiskFDA
Philips Medical Systems Nederlands
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005...
Diagnostic Devices·7,209 affected·Feb 19, 2019
RecallFDA
Randox Laboratories Ltd.
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as ass...
Diagnostic Devices·4 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as...
Diagnostic Devices·58 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic us...
Diagnostic Devices·12 affected·Feb 7, 2019
High RiskFDA
Medica Corporation
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in w...
Diagnostic Devices·87 affected·Feb 6, 2019
High RiskFDA
Abbott Ireland Diagnostics Division
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CM...
Diagnostic Devices·2,724 affected·Feb 5, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measur...
Diagnostic Devices·1,448 affected·Jan 22, 2019
High RiskFDA
Becton Dickinson & Co.
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacteria...
Diagnostic Devices·1,583 affected·Jan 14, 2019
RecallFDA
Lin-zhi International Inc
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster de...
Diagnostic Devices·49 affected·Jan 11, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quant...
Diagnostic Devices·304 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitat...
Diagnostic Devices·31 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quant...
Diagnostic Devices·79 affected·Jan 10, 2019