Reported Dec 3, 2025 · Ongoing
FlexLab (FLX); Version: FLX-217-10;
Inpeco S.A.
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: Inpeco S.A. · Via San Gottardo 10 · Lugano, N/A · N/A
Is this the product you have?
- FlexLab (FLX)
- VersionFLX-217-10
- Lot codes and dates
- UDI-DI07640172340004
- Serial numberFLX.0226
- Amount recalled
- 1 unit (OUS only)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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