Category

Diagnostic Devices Recalls

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

1,863 recalls
RecallFDA
Roche Diagnostics Operations, Inc.
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determinat...
Diagnostic Devices·7,032 affected·Sep 11, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry...
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-...
Diagnostic Devices·1,365,545 affected·Sep 10, 2019
High RiskFDA
Novarad Corporation
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display im...
Diagnostic Devices·197 affected·Sep 10, 2019
High RiskFDA
Beckman Coulter Inc.
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and ...
Diagnostic Devices·1,610 affected·Sep 4, 2019
High RiskFDA
Philips Ultrasound Inc
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ult...
Diagnostic Devices·0 affected·Aug 30, 2019
High RiskFDA
Philips Ultrasound Inc
Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound sy...
Diagnostic Devices·0 affected·Aug 30, 2019
High RiskFDA
Philips Ultrasound Inc
Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultra...
Diagnostic Devices·0 affected·Aug 30, 2019
High RiskFDA
Pajunk Gmbh
SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22...
Diagnostic Devices·40,475 affected·Aug 30, 2019
High RiskFDA
Beckman Coulter Inc
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Diagnostic Devices·0 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Diagnostic Devices·2,581 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Diagnostic Devices·16,983 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vit...
Diagnostic Devices·25,383 affected·Aug 15, 2019
High RiskFDA
Wom World Of Medicine Ag
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic a...
Diagnostic Devices·322 affected·Aug 14, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ ...
Diagnostic Devices·169 affected·Aug 14, 2019
High RiskFDA
Randox Laboratories Ltd.
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are ...
Diagnostic Devices·100 affected·Aug 9, 2019
RecallFDA
Randox Laboratories Ltd.
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality c...
Diagnostic Devices·1 affected·Jul 25, 2019
High RiskFDA
Neurologica Corporation
WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01...
Diagnostic Devices·5,088 affected·Jul 25, 2019
High RiskFDA
Neurologica Corporation
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00...
Diagnostic Devices·3,582 affected·Jul 25, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies...
Diagnostic Devices·139 affected·Jul 23, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Diagnostic Devices·12,796 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Diagnostic Devices·10,928 affected·Jul 22, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Diagnostic Devices·3,627 affected·Jul 22, 2019
High RiskFDA
Aniara Diagnostica Llc
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Diagnostic Devices·51 affected·Jul 19, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Diagnostic Devices·550 affected·Jul 16, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on ...
Diagnostic Devices·815 affected·Jul 15, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Diagnostic Devices·2 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Diagnostic Devices·17 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
Diagnostic Devices·44 affected·Jul 9, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
Diagnostic Devices·143 affected·Jul 9, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used wi...
Diagnostic Devices·95 affected·Jul 8, 2019
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric ...
Diagnostic Devices·467 affected·Jul 8, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in...
Diagnostic Devices·4,309 affected·Jul 2, 2019
High RiskFDA
Beckman Coulter Inc.
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 60...
Diagnostic Devices·10,145 affected·Jun 12, 2019
High RiskFDA
Randox Laboratories, Limited
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the qualit...
Diagnostic Devices·149 affected·Jun 11, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scala...
Diagnostic Devices·1,763 affected·Jun 10, 2019
RecallFDA
Randox Laboratories, Limited
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Diagnostic Devices·4 affected·Jun 10, 2019
High RiskFDA
Roche Diagnostics Corporation
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibod...
Diagnostic Devices·8 affected·Jun 3, 2019
RecallFDA
Abbott Laboratories
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of syst...
Diagnostic Devices·6,623 affected·May 24, 2019
High RiskFDA
Abbott Gmbh & Co. Kg
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Modul...
Diagnostic Devices·943 affected·May 21, 2019
High RiskFDA
Ge Healthcare, Llc
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device...
Diagnostic Devices·50 affected·May 17, 2019
High RiskFDA
Qiagen Sciences, Inc.
RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from ...
Diagnostic Devices·31 affected·May 6, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry C...
Diagnostic Devices·3,386 affected·May 3, 2019
High RiskFDA
Oakworks Inc
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tab...
Diagnostic Devices·3 affected·May 2, 2019
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utili...
Diagnostic Devices·9 affected·May 1, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access ...
Diagnostic Devices·238,862 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family o...
Diagnostic Devices·150,887 affected·Apr 30, 2019