Recall Z-0595-2026— Inpeco S.A.

Name: FDA recall Z-0595-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-30

Class II · Ongoing

Class II FDA medical device recall by Inpeco S.A., initiated 2025-10-30. It names one FDA 510(k) clearance: K121012. Product: FlexLab (FLX); Version: FLX-217-10;. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-30
Firm location: Lugano, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K121012 — FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.·cleared 2012-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.