Inpeco S.A.: Device Recall

Recall Details

Recall Number

Z-0107-2026

Classification

Class II

Product Type

Device

Recalling Firm

Inpeco S.A.

Status

Ongoing

Date Initiated

09/03/2025

Location

Lugano, Switzerland

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1 unit

Reason for Recall

The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

Product Description

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

Distribution Pattern

US distribution to CA & NY.

Other Recalls by Inpeco S.A.

• Class II: Risk 10/30/2025
  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: Risk 10/30/2025
  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: Risk 09/03/2025
  The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

View all recalls by Inpeco S.A. →