Inpeco S.A. recalls FlexLab (FLX); Version: FLX-217-40;

Recall date

October 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0596-2026

FDA classification

Class II

Brand / firm

Inpeco S.A.

Sold / distributed

US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FlexLab (FLX); Version: FLX-217-40;