FDA-Device2026-10-27Class IIPROCESSING DEFECT
BioMerieux EMAG system recalled over software error delaying results
What this means
BioMerieux is recalling a limited number of EMAG nucleic acid sample preparation instruments used in clinical labs. After updating to firmware SP4 Patch 2, a random software error (Error 10003, Heater timeout) can cause delayed or no results when analyzing clinical samples. No injuries have been reported.
- Check whether your EMAG system's serial number is on the affected list in the recall notice.
- Contact BioMerieux for guidance on affected instruments before relying on their results.
- If you see Error 10003, expect possible delays and follow your lab's backup testing plan.
The agency's original wording
Hazard
Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2
Intended for
All ages (under 100 years)
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of CA, IN, KS, LA, MN, MO, NY, OH, and TX. The countries of Canada, United Kingdom, Sweden, France, Norway, Netherlands, Belgium, Denmark, Germany, Austria.
Affected count
33
Manufactured in
Chemin De L'Orme, Marcy L'Etoile, France
Products
EMAG system
Model/Catalog Number: 418591/418591U
Product Description: Nucleic acid sample preparation instrument IVD, automated
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2027Want us to check the next one for you?
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