FDA Medical devices recall ·
EMAG system Model recall
- Recall number
- Z-0301-2027
- Date
- (initiated September 11, 2026)
- Company / brand
- BioMerieux SA
Chemin De L'Orme, Marcy L'Etoile, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 33
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Indiana Kansas Louisiana Minnesota Missouri New York Ohio Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0301-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.