Inpeco S.A. — FlexLab (FLX); Version: FLX-217-40;
⚠️ 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-217-40;
- Brand
- Inpeco S.A.
- Lot code
- UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046;
Additional details
UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14 units (1 US, 13 OUS).
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