Roche Diagnostics recalls
Roche Diagnostics appears in 39 official U.S. recall notices indexed by RecallRadar, most recently on 2019-07-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- The Tina-quant lgA Gen.2 is an immunoturbidimetric assay
FDA Device · Class II · 2019-07-24 · Roche Diagnostics - cobas p 701 post-analytical units, Part Number 05349966001
FDA Device · Class III · 2019-07-10 · Roche Diagnostics - cobas p 501 post-analytical units, Part Number 05158494001
FDA Device · Class III · 2019-07-10 · Roche Diagnostics - Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
FDA Device · Class II · 2019-05-29 · Roche Diagnostics - cobas e 801 immunoassay analyzer
FDA Device · Class II · 2019-05-08 · Roche Diagnostics - Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/H…
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Bilirubin Total Gen.3, Cat
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quan…
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnos…
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quan…
FDA Device · Class II · 2019-04-17 · Roche Diagnostics - cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190
FDA Device · Class II · 2019-04-17 · Roche Diagnostics - Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro quali…
FDA Device · Class II · 2019-02-06 · Roche Diagnostics - CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160
FDA Device · Class I · 2018-11-14 · Roche Diagnostics - Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photom…
FDA Device · Class II · 2018-11-07 · Roche Diagnostics - Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully autom…
FDA Device · Class II · 2018-09-05 · Roche Diagnostics - Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative d…
FDA Device · Class II · 2018-07-18 · Roche Diagnostics - Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative d…
FDA Device · Class II · 2018-07-18 · Roche Diagnostics - cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vit…
FDA Device · Class II · 2018-06-20 · Roche Diagnostics - Cobas b 221<4>Roche OMNI S4 system
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated cr…
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - cobas b 221 AutoQC Module Complete
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - cobas b 221<6>Roche OMNI S6 system
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
FDA Device · Class II · 2018-05-02 · Roche Diagnostics - Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA…
FDA Device · Class II · 2018-04-11 · Roche Diagnostics - cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001…
FDA Device · Class II · 2018-04-04 · Roche Diagnostics - c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036…
FDA Device · Class II · 2018-04-04 · Roche Diagnostics - Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 0…
FDA Device · Class II · 2018-04-04 · Roche Diagnostics - cobas 6000 Modular Series system
FDA Device · Class II · 2018-03-14 · Roche Diagnostics - cobas 8000 Modular Analyzer Series
FDA Device · Class II · 2018-03-14 · Roche Diagnostics - Cobas 8000 Modular Series system
FDA Device · Class II · 2018-02-28 · Roche Diagnostics - cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04…
FDA Device · Class II · 2018-02-07 · Roche Diagnostics - Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (d…
FDA Device · Class II · 2018-02-07 · Roche Diagnostics - Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Com…
FDA Device · Class II · 2018-01-24 · Roche Diagnostics - Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p…
FDA Device · Class II · 2017-06-14 · Roche Diagnostics - Elecsys PreciControl Varia 3
FDA Device · Class II · 2017-06-07 · Roche Diagnostics - Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 7…
FDA Device · Class II · 2017-05-17 · Roche Diagnostics - Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
FDA Device · Class II · 2017-04-19 · Roche Diagnostics - Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
FDA Device · Class II · 2017-04-19 · Roche Diagnostics - cobas p 612 pre-analytical system
FDA Device · Class II · 2017-02-01 · Roche Diagnostics