Official recall record
Kit Cobas 6800/8800 Sars-Cov-2/Flu
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-01-05
- Last updated (per notice)
- 2024-02-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Roche received customer complaints alleging the generation of false negative influenza a (flu a) results and late flu a target CT values when using the Cobas® Cars-Cov-2 & influenza a/b qualitative for use on Cobas® 6800/8800 systems. These allegations are specific to recently circulating mutations (single or double mutation) in h1n1pdm09 pertinent to the region of interest of the aforementioned test. Recall start date: December 22, 2022
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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