Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Beckman Coulter Inc.
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, wh...
Diagnostic Devices·8,774 affected·Apr 17, 2013
High RiskFDA
Biomerieux Sa
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determinati...
Diagnostic Devices·2,160 affected·Apr 17, 2013
High RiskFDA
Becton Dickinson & Co.
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococc...
Diagnostic Devices·610 affected·Apr 12, 2013
High RiskFDA
Paa Laboratories Inc
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in ce...
Diagnostic Devices·280,000 affected·Apr 12, 2013
High RiskFDA
Becton Dickinson & Co.
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
Diagnostic Devices·610 affected·Apr 12, 2013
High RiskFDA
Remel Inc
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle o...
Diagnostic Devices·150 affected·Apr 4, 2013
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use ...
Diagnostic Devices·3,019 affected·Apr 3, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine ...
Diagnostic Devices·478 affected·Apr 1, 2013
High RiskFDA
Ge Healthcare, Llc
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and obliq...
Diagnostic Devices·70 affected·Mar 28, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that meas...
Diagnostic Devices·490 affected·Mar 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Diagnostic Devices·3,871 affected·Mar 13, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, ...
Diagnostic Devices·189 affected·Mar 1, 2013
CriticalFDA
Natus Neurology Incorporated
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 ch...
Diagnostic Devices·114 affected·Feb 27, 2013
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH1...
Diagnostic Devices·79,869 affected·Feb 27, 2013
RecallFDA
Alere San Diego, Inc.
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chr...
Diagnostic Devices·78 affected·Feb 26, 2013
High RiskFDA
Clinical Diagnostic Solutions
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the perfor...
Diagnostic Devices·3,540 affected·Feb 24, 2013
RecallFDA
Remel Inc
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B ...
Diagnostic Devices·96 affected·Feb 19, 2013
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the...
Diagnostic Devices·579 affected·Feb 12, 2013
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative...
Diagnostic Devices·3,500 affected·Feb 12, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagn...
Diagnostic Devices·2,061 affected·Feb 8, 2013
High RiskFDA
Vital Images, Inc.
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and ...
Diagnostic Devices·7,649 affected·Feb 5, 2013
High RiskFDA
Diagnostica Stago, Inc.
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF...
Diagnostic Devices·2,901 affected·Jan 28, 2013
RecallFDA
Bion Enterprises Ltd
Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluore...
Diagnostic Devices·504 affected·Jan 23, 2013
RecallFDA
Bion Enterprises Ltd
Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescen...
Diagnostic Devices·207 affected·Jan 23, 2013
RecallFDA
Alere San Diego, Inc.
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromato...
Diagnostic Devices·2,167 affected·Jan 21, 2013
High RiskFDA
Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making...
Diagnostic Devices·116 affected·Jan 16, 2013
High RiskFDA
Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Univ...
Diagnostic Devices·177 affected·Jan 16, 2013
High RiskFDA
Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This s...
Diagnostic Devices·66 affected·Jan 16, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·5 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·64 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·56 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·10 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·50 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·202 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·273 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·522 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·5 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·202 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·46 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·19 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·25 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·141 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·32 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·867 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·46 affected·Jan 11, 2013
High RiskFDA
Veridex, Llc
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose labo...
Diagnostic Devices·82 affected·Dec 28, 2012
High RiskFDA
Veridex, Llc
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laborato...
Diagnostic Devices·70 affected·Dec 28, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sys...
Diagnostic Devices·1 affected·Dec 20, 2012