Category

Diagnostic Devices Recalls

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

1,863 recalls
RecallFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer de...
Diagnostic Devices·3 affected·Jan 2, 2019
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma...
Diagnostic Devices·24,995 affected·Jan 2, 2019
High RiskFDA
Philips Healthcare
DigitalDiagnost C50, Stationary X-ray System
Diagnostic Devices·2 affected·Dec 21, 2018
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and d...
Diagnostic Devices·297 affected·Dec 20, 2018
High RiskFDA
Abbott Gmbh & Co. Kg
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage:...
Diagnostic Devices·434 affected·Dec 20, 2018
High RiskFDA
Meridian Bioscience Inc
PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a sc...
Diagnostic Devices·184 affected·Dec 17, 2018
High RiskFDA
Roche Diagnostics Corporation
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vit...
Diagnostic Devices·5,292 affected·Dec 17, 2018
High RiskFDA
Roche Diagnostics Corporation
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tin...
Diagnostic Devices·656 affected·Dec 14, 2018
High RiskFDA
Roche Diagnostics Corporation
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Trigly...
Diagnostic Devices·137 affected·Dec 14, 2018
High RiskFDA
Biomerieux, Inc.
VITEK 2 AST-N351 Test Kit
Diagnostic Devices·30,292 affected·Dec 13, 2018
High RiskFDA
Luminex Corporation
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Diagnostic Devices·1 affected·Dec 10, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
Diagnostic Devices·10,414 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Diagnostic Devices·1,489 affected·Dec 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
Diagnostic Devices·114 affected·Dec 7, 2018
High RiskFDA
Randox Laboratories Ltd.
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Diagnostic Devices·225 affected·Dec 4, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·133 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·85 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·141 affected·Dec 3, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adr...
Diagnostic Devices·1,085 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA...
Diagnostic Devices·19,366 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human ser...
Diagnostic Devices·992 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human ser...
Diagnostic Devices·26,745 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiod...
Diagnostic Devices·24,083 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human se...
Diagnostic Devices·29,645 affected·Nov 30, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS...
Diagnostic Devices·4,030 affected·Nov 29, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Progesterone Reagent Kit, List Number 08P3620
Diagnostic Devices·157 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Diagnostic Devices·27 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Estradiol Reagent Kit, List Number 07P5020
Diagnostic Devices·79 affected·Nov 21, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
Alinity i Free T4 Reagent Kit, List Number 07P7030
Diagnostic Devices·294 affected·Nov 21, 2018
High RiskFDA
Randox Laboratories Ltd.
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprot...
Diagnostic Devices·250 affected·Nov 19, 2018
High RiskFDA
Diagnostica Stago, Inc.
Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of ...
Diagnostic Devices·22,342 affected·Nov 14, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Diagnostic Devices·146 affected·Nov 7, 2018
High RiskFDA
Stephanix
STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Rem...
Diagnostic Devices·17 affected·Nov 2, 2018
High RiskFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems...
Diagnostic Devices·14 affected·Nov 1, 2018
High RiskFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion ...
Diagnostic Devices·216 affected·Nov 1, 2018
High RiskFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employ...
Diagnostic Devices·372 affected·Nov 1, 2018
High RiskFDA
Wom World Of Medicine Ag
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combinat...
Diagnostic Devices·124,180 affected·Oct 22, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes...
Diagnostic Devices·682 affected·Oct 19, 2018
High RiskFDA
Eurotrol Inc
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assaye...
Diagnostic Devices·2,122 affected·Oct 18, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipettin...
Diagnostic Devices·1,649 affected·Oct 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetti...
Diagnostic Devices·1,628 affected·Oct 16, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparti...
Diagnostic Devices·191,410 affected·Oct 12, 2018
High RiskFDA
Abbott Ireland Diagnostics Division
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Micropart...
Diagnostic Devices·191,410 affected·Oct 12, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lacta...
Diagnostic Devices·13,435 affected·Oct 11, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing...
Diagnostic Devices·95 affected·Sep 28, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of im...
Diagnostic Devices·395 affected·Sep 28, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay...
Diagnostic Devices·7 affected·Sep 28, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: Th...
Diagnostic Devices·490 affected·Sep 26, 2018