Biomerieux Sa: Clinical Sample Concentrator
Recall Summary BioMerieux SA is recalling EMAG system nucleic acid sample preparation instruments (models 418591/418591U) worldwide due to a software error that can cause the system to fail to produce results when analyzing clinical samples. The error, which occurs randomly after a recent firmware update, generates a "Heater timeout" message. This recall affects laboratories and healthcare facilities in the US, Canada, and multiple European countries that use this equipment for sample preparation.
- Recalling firm
- BioMerieux SA
- Product
- EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
- Reason
- 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
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d79e32cc-13f1-48bf-ba22-3084256bd78c