Device recall
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
- Recall number
- Z-0301-2027
- Event id
- 99931
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- BioMerieux SA
- Report date
- Nov 4, 2026
- Posted
- Oct 27, 2026
- Initiated
- Sep 11, 2026
- Center classification date
- Oct 27, 2026
- Product code
- JJH
- Device type
- Clinical Sample Concentrator
- 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
- Root cause
- Software change control
- Quantity
- 33
- Code info
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Marcy L'Etoile, France