Official recall record
EMAG® Instrument
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-02
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
bioMérieux received complaints from the field related to EMAG® system Reference 418591 Error 10003 Heater timeout issues. The risk associated with the referenced issue is a potential delayed result / no result (loss of sample). Initial investigation of the issue identified the error started to occur on the field after firmware SP4 Patch 2 was installed. The investigation is ongoing to identify the root cause of the 10003-error heater timeout issue.
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 2026-10-15.
Record last checked against the registry on 2026-10-15.
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