BioMerieux SA recalls EMAG system
- Recalling company
- 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 II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 11, 2026
- Reported
- Nov 4, 2026
- 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.
- Status
- Ongoing
- Quantity
- 33
- Lot / codes
- UDI-DI 357302BUDI000544TP Serial Numbers IM03343 IM03283 IM03104 IM03329 IM03376 IM03474 IM03321 IM03071 IM03175 IM03194 IM03515 IM03516 IM03240 IM03478 IM03479 IM03482 IM03034 IM03092 IM03378 IM03414 IM03177 IM03193 IM03506 IM3054 IM03439 IM03350 IM03380 IM03131 IM03148 IM03153 IM03275 IM03314 IM03351
- Company location
- Marcy L'Etoile
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0301-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0301-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.