Z-0106-2026 Class II Ongoing
FDA device recall Z-0106-2026 was initiated by Inpeco S.A. on September 3, 2025 and is designated Class II. 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 effec… The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 15, 2025
- Initiation Date
- September 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
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.
Distribution Pattern
US distribution to CA & NY.
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.