Medical Device Recall: FlexLab (FLX); Version: FLX-217-40;
Inpeco S.A. · October 30, 2025
Reason for Recall
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
Distribution
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
States Affected
MI
Quantity Affected
14 units (1 US, 13 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0596-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.