Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Vital Images, Inc.
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as ...
Diagnostic Devices·598 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that a...
Diagnostic Devices·20 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic gui...
Diagnostic Devices·0 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are ...
Diagnostic Devices·5 affected·Oct 21, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Sl...
Diagnostic Devices·548,663 affected·Oct 17, 2013
High RiskFDA
Philips Medical Systems North America Inc.
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Diagnostic Devices·306 affected·Oct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemis...
Diagnostic Devices·19,368 affected·Oct 17, 2013
RecallFDA
Nanosphere, Inc.
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. ...
Diagnostic Devices·280 affected·Oct 16, 2013
High RiskFDA
Microgenics Corp
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by ...
Diagnostic Devices·370 affected·Oct 16, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva II
Diagnostic Devices·238 affected·Oct 14, 2013
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc...
Diagnostic Devices·33 affected·Oct 11, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection...
Diagnostic Devices·80 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitativ...
Diagnostic Devices·400 affected·Oct 10, 2013
High RiskFDA
Arrow International Inc
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices in...
Diagnostic Devices·294,430 affected·Oct 9, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower Us...
Diagnostic Devices·2,038 affected·Oct 7, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products COCM Reagent
Diagnostic Devices·3,342 affected·Oct 4, 2013
RecallFDA
Lin-zhi International Inc
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. ...
Diagnostic Devices·60 affected·Oct 3, 2013
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative,...
Diagnostic Devices·16,154 affected·Oct 2, 2013
High RiskFDA
Siemens Healthcare Diagnostics
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF ...
Diagnostic Devices·1,191 affected·Sep 24, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, au...
Diagnostic Devices·1,025 affected·Sep 24, 2013
High RiskFDA
Medrad Inc Dba Bayer R&i
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast me...
Diagnostic Devices·133 affected·Sep 20, 2013
High RiskFDA
Ge Healthcare, Llc
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advanta...
Diagnostic Devices·1,458 affected·Sep 19, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measur...
Diagnostic Devices·302 affected·Sep 18, 2013
High RiskFDA
Sekisui Diagnostics Llc
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualita...
Diagnostic Devices·391 affected·Sep 16, 2013
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitat...
Diagnostic Devices·8 affected·Sep 12, 2013
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle con...
Diagnostic Devices·2,658 affected·Sep 6, 2013
High RiskFDA
Seppim Sas
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZ...
Diagnostic Devices·47 affected·Sep 4, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein me...
Diagnostic Devices·892 affected·Sep 3, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein me...
Diagnostic Devices·625 affected·Sep 3, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patient...
Diagnostic Devices·810 affected·Aug 30, 2013
High RiskFDA
Vital Diagnostics, Inc.
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and...
Diagnostic Devices·213 affected·Aug 29, 2013
High RiskFDA
Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IM...
Diagnostic Devices·2,201 affected·Aug 27, 2013
High RiskFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidu...
Diagnostic Devices·38 affected·Aug 27, 2013
High RiskFDA
Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tes...
Diagnostic Devices·4,695 affected·Aug 27, 2013
High RiskFDA
Carestream Health Inc.
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system ...
Diagnostic Devices·4 affected·Aug 20, 2013
High RiskFDA
Sonogage Inc
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Diagnostic Devices·564 affected·Aug 9, 2013
High RiskFDA
Philips Healthcare Inc.
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Diagnostic Devices·89 affected·Aug 8, 2013
High RiskFDA
Ge Healthcare, Llc
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and ser...
Diagnostic Devices·225 affected·Aug 7, 2013
High RiskFDA
Toshiba American Medical Systems Inc
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Diagnostic Devices·427 affected·Aug 5, 2013
High RiskFDA
Toshiba American Medical Systems Inc
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Diagnostic Devices·430 affected·Aug 5, 2013
High RiskFDA
Leica Biosystems Newcastle Ltd.
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Bent...
Diagnostic Devices·1 affected·Jul 31, 2013
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or uni...
Diagnostic Devices·1,546 affected·Jul 30, 2013
High RiskFDA
Sarken, Inc.
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Diagnostic Devices·0 affected·Jul 29, 2013
High RiskFDA
Sarken, Inc.
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Diagnostic Devices·0 affected·Jul 29, 2013
High RiskFDA
Sarken, Inc.
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Diagnostic Devices·0 affected·Jul 29, 2013
High RiskFDA
Sarken, Inc.
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Diagnostic Devices·0 affected·Jul 29, 2013
High RiskFDA
Velocity Medical Solutions, Llc
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (phy...
Diagnostic Devices·54 affected·Jul 25, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of fol...
Diagnostic Devices·44 affected·Jul 25, 2013