Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic ...
Diagnostic Devices·2,838 affected·Oct 13, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic A...
Diagnostic Devices·2,838 affected·Oct 13, 2020
High RiskFDA
Microbiologics Inc
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance ...
Diagnostic Devices·46 affected·Oct 8, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immuno...
Diagnostic Devices·691 affected·Sep 30, 2020
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals w...
Diagnostic Devices·651 affected·Sep 30, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine...
Diagnostic Devices·23 affected·Sep 22, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in...
Diagnostic Devices·28 affected·Sep 22, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems de...
Diagnostic Devices·100 affected·Sep 18, 2020
High RiskFDA
Quidel Corporation
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with...
Diagnostic Devices·10,537 affected·Sep 17, 2020
RecallFDA
Invivo Corporation
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anato...
Diagnostic Devices·12,764 affected·Sep 14, 2020
High RiskFDA
Esaote S.p.a
AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following ...
Diagnostic Devices·989 affected·Sep 8, 2020
High RiskFDA
Esaote S.p.a
AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following ...
Diagnostic Devices·989 affected·Sep 8, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arteri...
Diagnostic Devices·463 affected·Aug 28, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of...
Diagnostic Devices·5,970 affected·Aug 25, 2020
High RiskFDA
Ameditech Inc
Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP ...
Diagnostic Devices·31,600 affected·Aug 18, 2020
High RiskFDA
Beckman Coulter Inc.
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent f...
Diagnostic Devices·219 affected·Aug 18, 2020
High RiskFDA
Tosoh Bioscience Inc
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-P...
Diagnostic Devices·39 affected·Aug 7, 2020
High RiskFDA
Tosoh Bioscience Inc
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is int...
Diagnostic Devices·289 affected·Aug 7, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-29...
Diagnostic Devices·2 affected·Aug 7, 2020
High RiskFDA
Inpeco S.a.
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-29...
Diagnostic Devices·10 affected·Aug 7, 2020
High RiskFDA
Carl Zeiss Meditec Ag
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive valu...
Diagnostic Devices·132 affected·Aug 6, 2020
High RiskFDA
Remel Europe Ltd.
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Borde...
Diagnostic Devices·79 affected·Jul 23, 2020
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 Software Version R1.0 and R1.1
Diagnostic Devices·322 affected·Jul 22, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For ...
Diagnostic Devices·2,349 affected·Jul 17, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals ...
Diagnostic Devices·1 affected·Jul 16, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Ch...
Diagnostic Devices·4,076 affected·Jul 13, 2020
RecallFDA
Orasure Technologies, Inc.
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for ...
Diagnostic Devices·13 affected·Jul 13, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration i...
Diagnostic Devices·149,370 affected·Jul 13, 2020
High RiskFDA
Randox Laboratories, Ltd.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Diagnostic Devices·1,497 affected·Jul 10, 2020
RecallFDA
Dna Genotek Inc.
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the ...
Diagnostic Devices·74 affected·Jun 24, 2020
High RiskFDA
Beckman Coulter Biomedical Gmbh
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling sys...
Diagnostic Devices·32 affected·Jun 17, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a ...
Diagnostic Devices·3,016 affected·Jun 15, 2020
High RiskFDA
Luminex Corporation
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a ...
Diagnostic Devices·3,016 affected·Jun 15, 2020
High RiskFDA
Philips North America, Llc
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Diagnostic Devices·52 affected·Jun 2, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Diagnostic Devices·779 affected·May 20, 2020
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use i...
Diagnostic Devices·1,555 affected·May 15, 2020
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use ...
Diagnostic Devices·0 affected·May 11, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies a...
Diagnostic Devices·230 affected·May 7, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 1084828...
Diagnostic Devices·15 affected·Apr 30, 2020
High RiskFDA
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Ki...
Diagnostic Devices·10,568 affected·Apr 14, 2020
High RiskFDA
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kit...
Diagnostic Devices·236 affected·Apr 14, 2020
High RiskFDA
Philips North America, Llc
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows,...
Diagnostic Devices·1,075 affected·Apr 13, 2020
High RiskFDA
The Binding Site Group, Ltd.
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry A...
Diagnostic Devices·36 affected·Apr 9, 2020
High RiskFDA
Philips North America, Llc
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Diagnostic Devices·346 affected·Apr 7, 2020
RecallFDA
Utak Laboratories Inc
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Contr...
Diagnostic Devices·1,395 affected·Mar 20, 2020
High RiskFDA
Welch Allyn, Inc/mortara
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Sc...
Diagnostic Devices·78,521 affected·Mar 18, 2020
High RiskFDA
Welch Allyn, Inc/mortara
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-le...
Diagnostic Devices·78,521 affected·Mar 18, 2020
RecallFDA
Ortho Clinical Diagnostics
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Diagnostic Devices·3,181 affected·Mar 10, 2020