Official recall record
CellMek SPS
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-09-04
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Issue #1- The instructions for use states that the dead volume for tubes in cassette B is 750ul and cassette E is 1300ul. However, testing shows that the dead volumes are actually 1582ul and 2093ul. Issue # 2- Cassette type E is not rocked prior to aspirating the specimen. Recall start date: August 27, 2025
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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