Inpeco S.A.: Medical Device Recall in 2025 - (Recall #: Z-0106-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

Product Classification:

Class II

Date Initiated: September 3, 2025

Date Posted: October 15, 2025

Recall Number: Z-0106-2026

Event ID: 97565

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 8 units

Code Information:

PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.

Distribution Pattern:

US distribution to CA & NY.

Voluntary or Mandated:

Voluntary: Firm initiated