In the agency's Nov 4, 2026 enforcement report · Ongoing
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD,…
BioMerieux SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile
Is this the product you have?
- EMAG system Model/Catalog Number418591/418591U
- Product DescriptionNucleic acid sample preparation instrument IVD, automated
- Lot codes and dates
- UDI-DI 357302BUDI000544TP Serial Numbers
IM03343IM03283IM03104IM03329IM03376IM03474IM03321IM03071IM03175IM03194IM03515IM03516IM03240IM03478IM03479IM03482IM03034IM03092IM03378IM03414IM03177IM03193IM03506IM3054IM03439IM03350IM03380IM03131IM03148IM03153IM03275IM03314IM03351
- UDI-DI 357302BUDI000544TP Serial Numbers
- Amount recalled
- 33
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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