Official recall record
cobas® c 303 analytical unit
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-15
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
An issue has been identified where vacuum tubing of the cell rinse unit of the cobas c 303 analytical unit prematurely deteriorated. Investigations confirmed the issue. In the event of small pinholes or cracks, no impact on analytical performance was identified. However, in case of tubing rupture, the following can occur as a result of the issue: Undetected leakage: Fluid may drip into random reaction cells. Result impact: Increased risk of erroneous patient and QC results.
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 2026-10-23.
Record last checked against the registry on 2026-10-23.
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