Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitat...
Diagnostic Devices·4 affected·May 17, 2016
High RiskFDA
Innovision A/s
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a numbe...
Diagnostic Devices·8 affected·May 13, 2016
High RiskFDA
Medical Vision Ab
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction durin...
Diagnostic Devices·3,295 affected·May 10, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho...
Diagnostic Devices·6,471 affected·May 9, 2016
RecallFDA
Leica Biosystems Richmond Inc.
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the patholog...
Diagnostic Devices·33 affected·May 6, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry s...
Diagnostic Devices·24,940 affected·May 5, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate A...
Diagnostic Devices·13,147 affected·May 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT Immunoassay System
Diagnostic Devices·292 affected·Apr 28, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and di...
Diagnostic Devices·165 affected·Apr 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Diagnostic Devices·80 affected·Apr 20, 2016
High RiskFDA
Helena Laboratories, Inc.
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPOR...
Diagnostic Devices·12 affected·Apr 20, 2016
RecallFDA
Ortho-clinical Diagnostics
The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Genera...
Diagnostic Devices·520 affected·Apr 19, 2016
High RiskFDA
Covidien Llc
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 ...
Diagnostic Devices·12,895 affected·Apr 15, 2016
High RiskFDA
Covidien Llc
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-031...
Diagnostic Devices·1,305 affected·Apr 15, 2016
RecallFDA
Affymetrix Inc
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. ...
Diagnostic Devices·507 affected·Apr 14, 2016
High RiskFDA
Beckman Coulter Inc.
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-L...
Diagnostic Devices·54,351 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination ...
Diagnostic Devices·43,877 affected·Apr 13, 2016
High RiskFDA
Beckman Coulter Inc.
Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipas...
Diagnostic Devices·32,926 affected·Apr 13, 2016
High RiskFDA
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information man...
Diagnostic Devices·28 affected·Apr 8, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative meas...
Diagnostic Devices·218 affected·Apr 6, 2016
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocy...
Diagnostic Devices·1,743 affected·Mar 31, 2016
RecallFDA
Biocare Medical, Llc
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Uni...
Diagnostic Devices·93 affected·Mar 31, 2016
High RiskFDA
Stryker Endoscopy
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 6...
Diagnostic Devices·489 affected·Mar 28, 2016
High RiskFDA
Ab Sciex
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers ...
Diagnostic Devices·2 affected·Mar 25, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial num...
Diagnostic Devices·1,301 affected·Mar 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics Inc.
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial nu...
Diagnostic Devices·1,300 affected·Mar 24, 2016
High RiskFDA
Remel Inc
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity ...
Diagnostic Devices·2 affected·Mar 24, 2016
RecallFDA
Becton, Dickinson And Company, Bd Biosciences
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Diagnostic Devices·205 affected·Mar 18, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Triglycerides (TGL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: ENZYMATIC CREATININE
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Direct HDL Cholesterol (AHDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) ...
Diagnostic Devices·19 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Triglycerides (TRIG)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Uric Acid (URCA)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-q...
Diagnostic Devices·8 affected·Mar 10, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated...
Diagnostic Devices·102,312 affected·Mar 7, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measur...
Diagnostic Devices·7,433 affected·Mar 7, 2016
CriticalFDA
Vascular Solutions, Inc.
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, a...
Diagnostic Devices·5,283 affected·Mar 4, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagno...
Diagnostic Devices·726 affected·Feb 26, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of med...
Diagnostic Devices·6 affected·Feb 24, 2016
High RiskFDA
Ab Sciex
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 50...
Diagnostic Devices·279 affected·Feb 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative me...
Diagnostic Devices·18,668 affected·Feb 16, 2016
High RiskFDA
Euro Diagnostica Ab
Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG anti...
Diagnostic Devices·25 affected·Feb 14, 2016
High RiskFDA
Ge Medical Systems, Llc
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-r...
Diagnostic Devices·817 affected·Feb 10, 2016
High RiskFDA
Ge Medical Systems, Llc
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for he...
Diagnostic Devices·25 affected·Feb 10, 2016