FlexLab (FLX); Version: FLX-217-10;
FDA Recall #Z-0595-2026 — Class II — October 30, 2025
Product Description
FlexLab (FLX); Version: FLX-217-10;
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.
Recalling Firm
Inpeco S.A. — Lugano, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit (OUS only)
Distribution
US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
Code Information
UDI-DI: 07640172340004 Serial number: FLX.0226;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated