Inpeco S.A. — FlexLab (FLX); Version: FLX-217-10;
⚠️ 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.
Is this relevant to me?
- Geography
- US, MI, UK
- Source agency
- FDA
- Category
- Health
- Published
- October 30, 2025
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
What's affected?
- Product
- FlexLab (FLX); Version: FLX-217-10;
- Brand
- Inpeco S.A.
- Lot code
- UDI-DI: 07640172340004 Serial number: FLX.0226;
Additional details
UDI-DI: 07640172340004 Serial number: FLX.0226;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit (OUS only).
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