Recall archive
64 recalls · page 2 of 3
Reported Dec 18, 2019
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90…
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — Due to low Quality Control recovery and invalid Calibration.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2019
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Inaccurately Low Sample Results
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2019
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details · Reason for recall — The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2019
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2017
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2016
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details · Reason for recall — Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can…
FDA (openFDA device enforcement)
Reported Nov 23, 2016
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Reason for recall — Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2016
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details · Reason for recall — cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following…
FDA (openFDA device enforcement)
Reported Nov 2, 2016
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details · Reason for recall — Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2016
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details · Reason for recall — Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the…
FDA (openFDA device enforcement)
Reported Apr 6, 2016
Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 30, 2016
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details — Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data…
FDA (openFDA device enforcement)
Reported Nov 25, 2015
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details — Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
FDA (openFDA device enforcement)
Reported Sep 2, 2015
cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2015
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid…
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when…
11 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2015
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details · Reason for recall — Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This…
FDA (openFDA device enforcement)
Reported Feb 11, 2015
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose…
FDA (openFDA device enforcement)
Reported Jan 7, 2015
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Reason for recall — Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2014
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details — The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor…
FDA (openFDA device enforcement)
Reported Oct 22, 2014
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are…
FDA (openFDA device enforcement)
Reported Sep 10, 2014
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that…
FDA (openFDA device enforcement)
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