| 2026-01-20 |
Class II
|
Ongoing |
Z-1476-2026 |
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464… |
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Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated… |
| 2025-11-21 |
Class II
|
Ongoing |
Z-1009-2026 |
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el… |
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Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as d… |
| 2024-10-17 |
Class II
|
Ongoing |
Z-0489-2025 |
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for… |
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Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative … |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3187-2024 |
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determina… |
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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 misdiagnosis… |
| 2023-10-03 |
Class II
|
Ongoing |
Z-0352-2024 |
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31… |
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Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. |
| 2022-12-12 |
Class II
|
Ongoing |
Z-0952-2023 |
cobas infinity central lab, Material Number 07154003001 |
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A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur wh… |
| 2022-07-14 |
Class II
|
Ongoing |
Z-1515-2022 |
cobas e801 Immunoassay Analyzer |
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Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HA… |
| 2021-10-18 |
Class II
|
Terminated |
Z-0266-2022 |
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of t… |
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A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was o… |
| 2021-06-24 |
Class II
|
Terminated |
Z-2444-2021 |
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 |
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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 automatic res… |
| 2021-04-26 |
Class II
|
Ongoing |
Z-1675-2021 |
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for th… |
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Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, … |
| 2021-04-07 |
Class II
|
Ongoing |
Z-1596-2021 |
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial inf… |
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Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT an… |
| 2021-04-07 |
Class II
|
Ongoing |
Z-1595-2021 |
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardia… |
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Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT an… |
| 2021-01-06 |
Class II
|
Terminated |
Z-1098-2021 |
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ioniz… |
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May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit … |
| 2020-12-17 |
Class II
|
Terminated |
Z-0883-2021 |
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process la… |
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A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an … |
| 2020-12-08 |
Class II
|
Ongoing |
Z-0755-2021 |
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (… |
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Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several af… |
| 2020-12-08 |
Class II
|
Ongoing |
Z-0754-2021 |
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 60… |
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Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several af… |
| 2020-12-02 |
Class II
|
Terminated |
Z-0804-2021 |
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulati… |
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Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR… |
| 2020-12-02 |
Class II
|
Terminated |
Z-0803-2021 |
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing… |
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Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR… |
| 2020-11-23 |
Class II
|
Terminated |
Z-0752-2021 |
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use |
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During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lea… |
| 2020-11-06 |
Class II
|
Terminated |
Z-0634-2021 |
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination… |
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Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702… |
| 2020-10-09 |
Class II
|
Terminated |
Z-0461-2021 |
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be use… |
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Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0086-2021 |
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001 |
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Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0085-2021 |
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 |
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Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and … |
| 2020-08-27 |
Class III
|
Terminated |
Z-0104-2021 |
Albumin Gen.2, Catalog 05166861190 |
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Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was ob… |
| 2020-08-27 |
Class III
|
Terminated |
Z-0103-2021 |
Tina-quant Complement C4 ver.2, Catalog 05991994190 |
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Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was ob… |
| 2020-08-20 |
Class II
|
Terminated |
Z-2981-2020 |
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190 |
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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 analyzers. There… |
| 2020-02-07 |
Class II
|
Terminated |
Z-1444-2020 |
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pa… |
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The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, whi… |
| 2020-01-07 |
Class II
|
Terminated |
Z-1158-2020 |
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use. |
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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 are doing … |