BioMerieux EMAG System Recalled for Software Error Causing Delayed Results
BioMerieux is recalling 33 EMAG systems due to a software error that can cause delayed or missing results when analyzing clinical samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for a software error causing delayed or no results in clinical sample analysis, which may lead to temporary adverse health consequences or remote probability of serious consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
BioMerieux SA is recalling 33 units of the EMAG system (Model/Catalog Number 418591/418591U), an automated nucleic acid sample preparation instrument. The recall is due to a randomly occurring software error, specifically Error 10003 Heater timeout, which can occur after updating to recent firmware SP4 Patch 2. This error may result in delayed or no results when analyzing clinical samples.
The affected units were distributed worldwide, including in the United States (CA, IN, KS, LA, MN, MO, NY, OH, and TX) and in Canada, the United Kingdom, Sweden, France, Norway, the Netherlands, Belgium, Denmark, and Germany. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should stop using the affected EMAG systems and contact BioMerieux for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
- Manufacturer
- BioMerieux SA
- Affected units
- 33
Distribution
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