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Roche Diagnostics Recalls
39 recalls on record · February 1, 2017 to July 24, 2019 · Medical Devices
Recalls by year
17
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 24, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form a
Hazard: Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
July 10, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Hazard: There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
July 10, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Hazard: There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
May 29, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinic
Hazard: Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
May 8, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer
Hazard: The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
April 24, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human ser
Hazard: The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
April 24, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidime
Hazard: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
April 24, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product
Hazard: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
April 24, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/
Hazard: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
April 17, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 0540147
Hazard: COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
April 17, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 0
Hazard: COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
February 6, 2019Medical DevicesFDA
Roche Diagnostics Corporation recalls Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used
Hazard: Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
November 14, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek X
Hazard: Abnormally high INR test results with the affected CoaguChek test strips
November 7, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer
Hazard: Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters
September 5, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a compute
Hazard: Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
July 18, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended
Hazard: The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
July 18, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended
Hazard: The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
June 20, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled anal
Hazard: The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
May 9, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer
Hazard: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
May 9, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer
Hazard: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
May 9, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyze
Hazard: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
May 9, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer
Hazard: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
May 2, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Hazard: The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."
April 11, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and
Hazard: Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
April 4, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack s
Hazard: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
April 4, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Num
Hazard: Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
April 4, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers:
Hazard: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
March 14, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Hazard: A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
March 14, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 50
Hazard: A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
February 28, 2018Medical DevicesFDA
Roche Diagnostics Corporation recalls Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Hazard: A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.