What's being recalled
Companies: Biomerieux Sa, 376, Chemin De L'Orme, Marcy-L'Etoile, France, 69280.
How to identify it
Affected products: EMAG® Instrument; Lot or serial number: IM03426; Model or catalogue number: 418591
Affected products: EMAG® Instrument; Lot or serial number: IM03274; Model or catalogue number: 418591
The hazard
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
Contact the importer.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)