EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid... recall (BioMerieux SA)
Medical deviceClass IIOngoing
Summary: BioMerieux SA is recalling 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.
What is being recalled
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Why
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: California, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, Ohio, Texas)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0301-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 11, 2026 |
| Reported | November 4, 2026 |
| Company | BioMerieux SA |
| Company location | Marcy L'Etoile, France |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 33 |
More recalls from BioMerieux SA · all medical device recalls · recalls from September 2026