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U.S. Department of Health and Human Services

Class 2 Device Recall EMAG

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 Class 2 Device Recall EMAGsee related information
Date Initiated by FirmSeptember 11, 2026
Date PostedOctober 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0301-2027
Recall Event ID 99931
Product Classification Clinical sample concentrator - Product Code JJH
ProductEMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Code Information 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
FEI Number 1000611339
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information ContactbioMerieux Customer Service Center
800-6822666
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Software change control
ActionThe firm began notifying consignees on September 11, 2026. Customers were informed they may continue use of EMAG systems and there is no risk of false results. In case of 10003 error heater time-out during an extraction protocol, customers are instructed to reset the system to run the protocol again to prevent delay/loss of sample. The company will contact customers to schedule a bioMerieux Field Service Engineer (FSE) visit to update affected EMAG systems to the previous firmware patch SP4 Patch 1 to fix the issue.
Quantity in Commerce33
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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