Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Philips Healthcare Inc.
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Diagnostic Devices·4 affected·Aug 14, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalc...
Diagnostic Devices·5 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA Cr...
Diagnostic Devices·1 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottle...
Diagnostic Devices·3 affected·Aug 10, 2012
High RiskFDA
Immunodiagnostics Systems Ltd
IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amin...
Diagnostic Devices·29 affected·Aug 10, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pac...
Diagnostic Devices·15 affected·Aug 7, 2012
High RiskFDA
Diamedix Corporation
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the...
Diagnostic Devices·65 affected·Aug 6, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed spec...
Diagnostic Devices·1,074 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed s...
Diagnostic Devices·140 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specif...
Diagnostic Devices·562 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed s...
Diagnostic Devices·46 affected·Aug 3, 2012
High RiskFDA
Instrumentation Laboratory Co.
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifi...
Diagnostic Devices·304 affected·Aug 3, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Op...
Diagnostic Devices·217 affected·Aug 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, ...
Diagnostic Devices·217 affected·Aug 1, 2012
RecallFDA
Roche Molecular Systems, Inc.
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the ...
Diagnostic Devices·44 affected·Jul 31, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phe...
Diagnostic Devices·79,744 affected·Jul 30, 2012
High RiskFDA
Bio-rad Laboratories
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitati...
Diagnostic Devices·7,400 affected·Jul 27, 2012
High RiskFDA
Quality Electrodynamics Llc
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be int...
Diagnostic Devices·17 affected·Jul 27, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the AD...
Diagnostic Devices·2 affected·Jul 25, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Int...
Diagnostic Devices·7 affected·Jul 25, 2012
High RiskFDA
Beckman Coulter Inc.
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay us...
Diagnostic Devices·5,266 affected·Jul 24, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (...
Diagnostic Devices·2,050 affected·Jul 17, 2012
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzer...
Diagnostic Devices·2,554 affected·Jul 17, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in hum...
Diagnostic Devices·1,894 affected·Jul 17, 2012
High RiskFDA
Roche Molecular Systems, Inc.
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various...
Diagnostic Devices·13 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic aci...
Diagnostic Devices·3,772 affected·Jul 16, 2012
High RiskFDA
Roche Molecular Systems, Inc.
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ T...
Diagnostic Devices·884 affected·Jul 16, 2012
High RiskFDA
Philips Healthcare Inc.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Diagnostic Devices·41 affected·Jul 11, 2012
RecallFDA
Iris Diagnostics
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an as...
Diagnostic Devices·862 affected·Jul 9, 2012
High RiskFDA
Fujifilm Medical System Usa, Inc.
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Diagnostic Devices·14 affected·Jun 29, 2012
High RiskFDA
Bd Biosciences, Systems & Reagents
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD F...
Diagnostic Devices·96 affected·Jun 29, 2012
High RiskFDA
Perkinelmer
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high ...
Diagnostic Devices·78 affected·Jun 27, 2012
High RiskFDA
Eos Imaging Inc
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Diagnostic Devices·12 affected·Jun 19, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for...
Diagnostic Devices·864 affected·Jun 8, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
Diagnostic Devices·822 affected·Jun 8, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-d...
Diagnostic Devices·786 affected·Jun 7, 2012
High RiskFDA
Sysmex America, Inc.
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, On...
Diagnostic Devices·69 affected·Jun 1, 2012
High RiskFDA
Sysmex America, Inc.
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One...
Diagnostic Devices·763 affected·Jun 1, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic ...
Diagnostic Devices·637 affected·May 29, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Adva...
Diagnostic Devices·363 affected·May 25, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client application...
Diagnostic Devices·38 affected·May 23, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique...
Diagnostic Devices·38 affected·May 22, 2012
CriticalFDA
Philips Healthcare Inc.
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
Diagnostic Devices·752 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique,...
Diagnostic Devices·5 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologiqu...
Diagnostic Devices·68 affected·May 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, Q...
Diagnostic Devices·57 affected·May 22, 2012
High RiskFDA
Alere San Diego, Inc.
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used w...
Diagnostic Devices·9,997 affected·May 14, 2012