Health product recall

EMAG® Instrument

Brand(s)
Last updated

Summary

Product
EMAG® Instrument
Issue
Medical devices - Performance
What to do

Contact the importer.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

EMAG® Instrument

IM03426

418591

EMAG® Instrument

IM03274

418591

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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Biomerieux Sa

376, Chemin De L'Orme, Marcy-L'Etoile, France, 69280

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82700

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