Category

Diagnostic Devices Recalls

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

1,863 recalls
CriticalFDA
Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System...
Diagnostic Devices·231,967 affected·Dec 5, 2014
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Diagnostic Devices·1,016 affected·Nov 29, 2014
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Diagnostic Devices·49 affected·Nov 29, 2014
High RiskFDA
Carestream Health Inc
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) ---...
Diagnostic Devices·629 affected·Nov 25, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobi...
Diagnostic Devices·1,230 affected·Nov 24, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitativ...
Diagnostic Devices·658 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VIT...
Diagnostic Devices·339 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-...
Diagnostic Devices·1,830 affected·Nov 19, 2014
RecallFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diag...
Diagnostic Devices·9 affected·Nov 17, 2014
High RiskFDA
Illumina Inc
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in th...
Diagnostic Devices·13 affected·Nov 13, 2014
High RiskFDA
Becton Dickinson & Co.
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959...
Diagnostic Devices·7 affected·Nov 7, 2014
RecallFDA
Illumina Inc
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Diagnostic Devices·19 affected·Nov 6, 2014
High RiskFDA
Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: ...
Diagnostic Devices·701 affected·Nov 5, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to ...
Diagnostic Devices·1,949 affected·Nov 5, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as a...
Diagnostic Devices·3,622 affected·Oct 27, 2014
High RiskFDA
Centurion Medical Products Corporation
Diagnostic Imaging Tray (General Surgery convenience kit)
Diagnostic Devices·760 affected·Oct 23, 2014
RecallFDA
Medtest Holdings, Inc.
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper a...
Diagnostic Devices·10,260 affected·Oct 23, 2014
High RiskFDA
Remel Inc
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pne...
Diagnostic Devices·59 affected·Oct 23, 2014
High RiskFDA
Data Innovations, Llc
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that p...
Diagnostic Devices·657 affected·Oct 23, 2014
High RiskFDA
Diamedix Corporation
Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitativ...
Diagnostic Devices·588 affected·Oct 20, 2014
High RiskFDA
Diamedix Corporation
Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitati...
Diagnostic Devices·94 affected·Oct 20, 2014
RecallFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULI...
Diagnostic Devices·2,212 affected·Oct 20, 2014
High RiskFDA
Diagnostic Hybrids Inc
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Diagnostic Devices·171 affected·Oct 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Diagnostic Devices·10,515 affected·Oct 9, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Diagnostic Devices·10,515 affected·Oct 9, 2014
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoas...
Diagnostic Devices·1,519 affected·Oct 6, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI...
Diagnostic Devices·1,519 affected·Oct 6, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro di...
Diagnostic Devices·1,733 affected·Sep 24, 2014
High RiskFDA
Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for th...
Diagnostic Devices·80 affected·Sep 23, 2014
High RiskFDA
Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for t...
Diagnostic Devices·320 affected·Sep 23, 2014
RecallFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems...
Diagnostic Devices·4,645 affected·Sep 12, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917...
Diagnostic Devices·0 affected·Sep 11, 2014
High RiskFDA
The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses ...
Diagnostic Devices·0 affected·Sep 11, 2014
High RiskFDA
Abbott Ireland Diagnostics Division
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES b...
Diagnostic Devices·7,415 affected·Sep 11, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is in...
Diagnostic Devices·97 affected·Sep 8, 2014
High RiskFDA
Ge Healthcare, Llc
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anat...
Diagnostic Devices·10 affected·Sep 4, 2014
High RiskFDA
Ge Healthcare, Llc
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human a...
Diagnostic Devices·1 affected·Sep 4, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiog...
Diagnostic Devices·1 affected·Sep 2, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applic...
Diagnostic Devices·2 affected·Sep 2, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiog...
Diagnostic Devices·10 affected·Sep 2, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diag...
Diagnostic Devices·307 affected·Aug 21, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative de...
Diagnostic Devices·236 affected·Aug 21, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry ...
Diagnostic Devices·339 affected·Aug 20, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory envir...
Diagnostic Devices·2,771 affected·Aug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Diagnostic Devices·1,517 affected·Aug 19, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environm...
Diagnostic Devices·2,771 affected·Aug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Diagnostic Devices·260 affected·Aug 19, 2014
High RiskFDA
Data Innovations, Llc
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides con...
Diagnostic Devices·84 affected·Aug 15, 2014