Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Bio-rad Laboratories, Inc.
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is inten...
Diagnostic Devices·791 affected·Sep 17, 2021
High RiskFDA
Bio-rad Laboratories, Inc.
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow...
Diagnostic Devices·11,610 affected·Sep 17, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Diagnostic Devices·11,408 affected·Sep 2, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Diagnostic Devices·5,855 affected·Sep 2, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro d...
Diagnostic Devices·60,563 affected·Sep 2, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Diagnostic Devices·71,314 affected·Sep 2, 2021
High RiskFDA
Philips Ultrasound Inc
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Diagnostic Devices·1 affected·Aug 19, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-se...
Diagnostic Devices·12 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system...
Diagnostic Devices·198 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-...
Diagnostic Devices·147 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sect...
Diagnostic Devices·1,517 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-se...
Diagnostic Devices·266 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-...
Diagnostic Devices·228 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross...
Diagnostic Devices·99 affected·Aug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce c...
Diagnostic Devices·42 affected·Aug 11, 2021
High RiskFDA
Beckman Coulter Inc.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Diagnostic Devices·293,640 affected·Aug 9, 2021
High RiskFDA
Luminex Corporation
Verigene EP Amplification Reagent Kit Test
Diagnostic Devices·4,579 affected·Aug 3, 2021
High RiskFDA
Philips North America Llc
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-s...
Diagnostic Devices·6 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·3 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·1 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cro...
Diagnostic Devices·2 affected·Jul 30, 2021
High RiskFDA
Philips North America Llc
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectio...
Diagnostic Devices·3 affected·Jul 30, 2021
High RiskFDA
Abbott Laboratories
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Diagnostic Devices·4,833 affected·Jul 26, 2021
High RiskFDA
Trophy Sas
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿...
Diagnostic Devices·895 affected·Jul 21, 2021
High RiskFDA
Beckman Coulter Inc.
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Diagnostic Devices·123 affected·Jul 21, 2021
High RiskFDA
Abbott Laboratories, Inc
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasm...
Diagnostic Devices·260 affected·Jul 12, 2021
RecallFDA
Stanbio Laboratory, Lp
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Diagnostic Devices·200 affected·Jul 12, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29...
Diagnostic Devices·437 affected·Jul 6, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer anti...
Diagnostic Devices·787 affected·Jul 6, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q flo...
Diagnostic Devices·70 affected·Jun 30, 2021
High RiskFDA
Biomerieux Inc
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Diagnostic Devices·1,431 affected·Jun 24, 2021
High RiskFDA
Abbott Laboratories
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,...
Diagnostic Devices·4,727 affected·Jun 10, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Diagnostic Devices·116 affected·May 27, 2021
High RiskFDA
Cytocell Ltd.
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Diagnostic Devices·23 affected·May 27, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
ProxiDiagnost N90. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Diagnostic Devices·140 affected·May 19, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs ...
Diagnostic Devices·842 affected·May 18, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Diagnostic Devices·233 affected·May 13, 2021
High RiskFDA
Beckman Coulter Inc.
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Diagnostic Devices·13,337 affected·May 7, 2021
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Diagnostic Devices·441 affected·May 7, 2021
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Diagnostic Devices·320 affected·May 7, 2021
High RiskFDA
Neumodx Molecular Inc
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Diagnostic Devices·620 affected·May 4, 2021
CriticalFDA
Quidel Corporation
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Diagnostic Devices·29,787 affected·Apr 27, 2021
CriticalFDA
Lepu Medical Technology (beijing) Co., Ltd
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/...
Diagnostic Devices·8 affected·Apr 26, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative de...
Diagnostic Devices·20,468 affected·Apr 26, 2021
CriticalFDA
Lepu Medical Technology (beijing) Co., Ltd
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antige...
Diagnostic Devices·8 affected·Apr 26, 2021