Indianapolis, IN, United States
Roche Diagnostics Corporation recalls
21 recalls recorded since 2018, most recently on 3 June 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls21
Ongoing (FDA)0
Terminated or completed21
Class I (FDA)1
Terminated Class II Medical devices
- Recall started
- 3 June 2019
- Terminated
- 28 August 2020
- Reason
- 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.
- Distribution
- The products were distributed to the following US states: AL, IN, and KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1979-2019
- The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
Terminated Class III Medical devices
- Recall started
- 4 April 2019
- Terminated
- 12 May 2020
- Reason
- There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
- Distribution
- US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1927-2019, Z-1928-2019
- cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
- cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Terminated Class II Medical devices
- Recall started
- 18 March 2019
- Terminated
- 28 August 2020
- Reason
- The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
- Distribution
- US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1194-2019
- Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Terminated Class II Medical devices
- Recall started
- 15 March 2019
- Terminated
- 23 April 2020
- Reason
- 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.
- Distribution
- Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1249-2019
- cobas e 801 immunoassay analyzer
Terminated Class II Medical devices
- Recall started
- 4 February 2019
- Terminated
- 16 September 2020
- Reason
- 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.
- Distribution
- US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1368-2019
- Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Terminated Class II Medical devices
- Recall started
- 17 December 2018
- Terminated
- 2 November 2020
- Reason
- 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***
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1146-2019, Z-1145-2019, Z-1147-2019
- Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative
- Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of
- Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated
Terminated Class II Medical devices
- Recall started
- 17 December 2018
- Terminated
- 10 April 2020
- Reason
- Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0784-2019
- Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in hum
Terminated Class II Medical devices
- Recall started
- 14 December 2018
- Terminated
- 4 September 2020
- Reason
- 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
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1124-2019, Z-1125-2019
- COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Ca
- cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-
Terminated Class II Medical devices
- Recall started
- 24 September 2018
- Terminated
- 9 February 2022
- Reason
- 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
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0301-2019
- Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5
Terminated Class I Medical devices
- Recall started
- 13 September 2018
- Terminated
- 16 October 2020
- Reason
- Abnormally high INR test results with the affected CoaguChek test strips
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0360-2019
- CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 077
Terminated Class II Medical devices
- Recall started
- 16 July 2018
- Terminated
- 16 May 2019
- Reason
- 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.
- Distribution
- US Distribution to states of: CA, NY,TX, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2944-2018
- Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-
Terminated Class II Medical devices
- Recall started
- 27 April 2018
- Terminated
- 11 May 2020
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2390-2018, Z-2389-2018
- Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This ass
- Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This ass
Terminated Class II Medical devices
- Recall started
- 3 April 2018
- Terminated
- 21 November 2019
- Reason
- 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.
- Distribution
- US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2136-2018
- cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 800
Terminated Class II Medical devices
- Recall started
- 22 February 2018
- Terminated
- 15 November 2019
- Reason
- The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Distribution
- USA ( nationwide)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1613-2018, Z-1610-2018, Z-1612-2018, Z-1611-2018
- cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2
- cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2
- cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO
- Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, P
Terminated Class II Medical devices
- Recall started
- 2 January 2018
- Terminated
- 25 April 2019
- Reason
- 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."
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1519-2018
- Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Terminated Class II Medical devices
- Recall started
- 22 December 2017
- Terminated
- 5 April 2019
- Reason
- 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.
- Distribution
- US Distribution in states of: CA, FL and IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1311-2018
- Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Terminated Class II Medical devices
- Recall started
- 18 December 2017
- Terminated
- 9 April 2019
- Reason
- Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1268-2018, Z-1270-2018, Z-1269-2018
- c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
- cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
- Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
Terminated Class II Medical devices
- Recall started
- 28 July 2017
- Terminated
- 10 June 2020
- Reason
- A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
- Distribution
- Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0675-2018
- Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Terminated Class II Medical devices
- Recall started
- 18 July 2017
- Terminated
- 13 July 2018
- Reason
- 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.
- Distribution
- Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0909-2018, Z-0910-2018
- cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 600
- cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Terminated Class II Medical devices
- Recall started
- 5 July 2017
- Terminated
- 30 April 2019
- Reason
- A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0498-2018, Z-0499-2018
- cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E11
- Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Med
Terminated Class II Medical devices
- Recall started
- 29 June 2017
- Terminated
- 24 January 2020
- Reason
- Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
- Distribution
- USA (nationwide) Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0378-2018
- Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.