FDA recall, , Moderate risk
BioMerieux EMAG Nucleic Acid Sample Preparation Instrument
The EMAG system can delay or produce no results when analyzing clinical samples due to a software error.
Summary by Recall Canary from the FDA notice
What happened
BioMerieux SA, located in Marcy L'Etoile, France, voluntarily initiated a recall of the EMAG system, a nucleic acid sample preparation instrument IVD, automated, due to a randomly occurring software error, Error 10003 Heater timeout, which can cause delayed or no results when analyzing clinical samples after updating to recent firmware SP4 Patch 2. The company began the recall on September 11, 2026, and customers were notified by letter.
The recall was added to the FDA's Enforcement Report and classified by the FDA on October 27, 2026, with the FDA's weekly enforcement report on November 4, 2026. Distribution was worldwide, including US nationwide distribution in California, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, Ohio and Texas, as well as the countries of Canada, United Kingdom, Sweden, France, Norway, Netherlands, Belgium, Denmark, Germany, and Austria.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and other code listed under your product.
EMAG system
- Model number
- 418591/418591U
- Other code
- 357302BUDI000544TP
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Worldwide - US Nationwide distribution in the states of California, Indiana, Kansas, Louisiana, Minnesota, Missouri, New York, Ohio, and Texas. The countries of Canada, United Kingdom, Sweden, France, Norway, Netherlands, Belgium, Denmark, Germany, Austria.
- Recalled by
- BioMerieux SAMarcy L'Etoile, France
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99931
- Recall number
- Z-0301-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from BioMerieux SA
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
BioMerieux SA began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
