Recall Monitor
Health Products

EMAG® Instrument

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: EMAG® Instrument
Issue: Medical devices - Performance
What to do: Contact the importer.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
EMAG® InstrumentIM03426418591
EMAG® InstrumentIM03274418591

Issue

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.

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