Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Diagnostic Devices·238 affected·Nov 8, 2017
CriticalFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualit...
Diagnostic Devices·227 affected·Nov 6, 2017
CriticalFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitat...
Diagnostic Devices·2 affected·Nov 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Diagnostic Devices·2 affected·Nov 1, 2017
High RiskFDA
Roche Molecular Systems, Inc.
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Diagnostic Devices·136 affected·Oct 27, 2017
High RiskFDA
Hitachi Medical Systems America Inc
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and...
Diagnostic Devices·55 affected·Oct 20, 2017
High RiskFDA
Siemens Healthcare Diagnostics
BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -00842768...
Diagnostic Devices·7,631 affected·Oct 17, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL...
Diagnostic Devices·268 affected·Oct 2, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
Diagnostic Devices·196 affected·Sep 22, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Diagnostic Devices·102 affected·Sep 22, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 36504...
Diagnostic Devices·1,976,000 affected·Sep 18, 2017
High RiskFDA
Hologic, Inc
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Diagnostic Devices·1 affected·Sep 15, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and bi...
Diagnostic Devices·265 affected·Aug 24, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Diagnostic Devices·213 affected·Aug 21, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. M...
Diagnostic Devices·98 affected·Aug 14, 2017
RecallFDA
Randox Laboratories
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Diagnostic Devices·117 affected·Aug 11, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. M...
Diagnostic Devices·11 affected·Aug 7, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum us...
Diagnostic Devices·33,298 affected·Jul 28, 2017
High RiskFDA
Optovue, Inc.
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is sui...
Diagnostic Devices·326 affected·Jul 27, 2017
High RiskFDA
Helena Laboratories, Corp.
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Diagnostic Devices·24 affected·Jul 21, 2017
High RiskFDA
Beckman Coulter Inc.
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, ...
Diagnostic Devices·320 affected·Jul 20, 2017
High RiskFDA
Kamiya Biomedical Company, Llc
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator ...
Diagnostic Devices·1,398 affected·Jul 19, 2017
High RiskFDA
Leica Biosystems Richmond Inc.
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse...
Diagnostic Devices·5 affected·Jul 14, 2017
High RiskFDA
Leica Biosystems Richmond Inc.
Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) ...
Diagnostic Devices·3 affected·Jul 14, 2017
High RiskFDA
Leica Biosystems Richmond Inc.
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin...
Diagnostic Devices·4 affected·Jul 14, 2017
High RiskFDA
Leica Biosystems Richmond Inc.
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-6...
Diagnostic Devices·33 affected·Jul 14, 2017
High RiskFDA
Leica Biosystems Richmond Inc.
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyc...
Diagnostic Devices·37 affected·Jul 14, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for t...
Diagnostic Devices·9,234 affected·Jul 12, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial sus...
Diagnostic Devices·1,866 affected·Jul 12, 2017
RecallFDA
Ortho Clinical Diagnostics Inc
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 460...
Diagnostic Devices·10,021 affected·Jul 10, 2017
High RiskFDA
Qualigen Inc
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Diagnostic Devices·493 affected·Jul 7, 2017
High RiskFDA
Roche Diagnostics Corporation
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/...
Diagnostic Devices·923 affected·Jul 5, 2017
High RiskFDA
Roche Diagnostics Corporation
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer ...
Diagnostic Devices·255 affected·Jul 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transfera...
Diagnostic Devices·33,233 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·19,991 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,056 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (hep...
Diagnostic Devices·7,014 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·181,072 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium h...
Diagnostic Devices·1,667 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·37,923 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·3,130 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·226 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·32,744 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,067 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·30,446 affected·Jun 29, 2017
High RiskFDA
Quidel Corporation
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in...
Diagnostic Devices·1,078 affected·Jun 22, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnos...
Diagnostic Devices·98 affected·May 31, 2017
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic ...
Diagnostic Devices·171,979 affected·May 23, 2017