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FDAOctober 30, 2025device

FlexLab (FLX); Version: FLX-217-10;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

inpeco

UPCs

07640172340004

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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