Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 103...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 103132...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic im...
Diagnostic Devices·33 affected·Aug 12, 2014
High RiskFDA
Sedecal S.a.
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Diagnostic Devices·283 affected·Aug 6, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408,...
Diagnostic Devices·1,122 affected·Aug 6, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C vir...
Diagnostic Devices·463 affected·Aug 6, 2014
High RiskFDA
Illumina Inc
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a...
Diagnostic Devices·35 affected·Jul 28, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is ...
Diagnostic Devices·1,099 affected·Jul 27, 2014
RecallFDA
Agfa Healthcare Corp.
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B...
Diagnostic Devices·2,617 affected·Jul 16, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ EC...
Diagnostic Devices·475 affected·Jul 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body flu...
Diagnostic Devices·2,757 affected·Jul 16, 2014
High RiskFDA
Ab Sciex
AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e....
Diagnostic Devices·6 affected·Jul 15, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VI...
Diagnostic Devices·5,906 affected·Jul 15, 2014
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded w...
Diagnostic Devices·1,045 affected·Jul 9, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended fo...
Diagnostic Devices·2 affected·Jul 8, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety ...
Diagnostic Devices·142 affected·Jul 7, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitr...
Diagnostic Devices·81 affected·Jul 7, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging sys...
Diagnostic Devices·192 affected·Jul 7, 2014
High RiskFDA
Advandx Inc
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that ...
Diagnostic Devices·10 affected·Jul 4, 2014
High RiskFDA
Agfa Healthcare Corp.
DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with dia...
Diagnostic Devices·17 affected·Jul 2, 2014
High RiskFDA
Biogenex Laboratories, Inc.
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Diagnostic Devices·4 affected·Jul 1, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, s...
Diagnostic Devices·13 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to coll...
Diagnostic Devices·2 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collec...
Diagnostic Devices·26 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to...
Diagnostic Devices·2 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect,...
Diagnostic Devices·9 affected·Jun 23, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to coll...
Diagnostic Devices·3 affected·Jun 23, 2014
High RiskFDA
Itc-nexus Dx
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Diagnostic Devices·315 affected·Jun 20, 2014
High RiskFDA
Agfa Corp.
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the ...
Diagnostic Devices·216 affected·Jun 6, 2014
High RiskFDA
Bd Biosciences, Systems & Reagents
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Diagnostic Devices·35 affected·Jun 6, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated fo...
Diagnostic Devices·1,053 affected·Jun 4, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all ...
Diagnostic Devices·3,460 affected·Jun 4, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc...
Diagnostic Devices·40 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Num...
Diagnostic Devices·3,839 affected·Jun 2, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·15 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·65 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·122 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·71 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·83 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·2 affected·May 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Diagnostic Devices·34,283 affected·May 30, 2014
High RiskFDA
Carestream Health Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently inst...
Diagnostic Devices·100 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·2 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·156 affected·May 30, 2014
CriticalFDA
Biofire Diagnostics, Inc.
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitativ...
Diagnostic Devices·1,084 affected·May 27, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 031497730...
Diagnostic Devices·462 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) ...
Diagnostic Devices·149 affected·May 21, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Ad...
Diagnostic Devices·5 affected·May 15, 2014