Recall archive
64 recalls · page 1 of 3
Reported Mar 11, 2026
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is…
FDA (openFDA device enforcement)
Reported Jan 14, 2026
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Reason for recall — Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis,…
FDA (openFDA device enforcement)
Reported Nov 27, 2024
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive…
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and…
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
FDA (openFDA device enforcement)
Reported Jan 18, 2023
cobas infinity central lab, Material Number 07154003001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA)…
FDA (openFDA device enforcement)
Reported Aug 17, 2022
cobas e801 Immunoassay Analyzer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the…
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite…
FDA (openFDA device enforcement)
Reported Sep 22, 2021
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This…
FDA (openFDA device enforcement)
Reported Jun 2, 2021
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for…
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 received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas…
FDA (openFDA device enforcement)
Reported May 26, 2021
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of…
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 — Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product details — May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision.…
FDA (openFDA device enforcement)
Reported Jan 27, 2021
A calculator/data processing module for clinical use is 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 · Reason for recall — A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas…
FDA (openFDA device enforcement)
Reported Jan 13, 2021
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 6, 2021
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2020
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative…
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 confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas…
FDA (openFDA device enforcement)
Reported Nov 25, 2020
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
FDA (openFDA device enforcement)
Reported Oct 21, 2020
Tina-quant Complement C4 ver.2, Catalog 05991994190
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Roche Diagnostics Operations, Inc.
Matched: Brand · Reason for recall — Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2020
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2020
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602…
FDA (openFDA device enforcement)
Reported Mar 11, 2020
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9…
FDA (openFDA device enforcement)
Reported Feb 19, 2020
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that…
FDA (openFDA device enforcement)
Reported Feb 5, 2020
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand — Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
FDA (openFDA device enforcement)
Reported Dec 25, 2019
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Roche Diagnostics Operations, Inc.
Matched: Brand · Product · Product details — Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
FDA (openFDA device enforcement)
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