FDA Medical devices recall ·
FlexLab X (FXX) System recall
- Recall number
- Z-0107-2026
- Date
- (initiated September 3, 2025)
- Company / brand
- Inpeco S.A.
Via San Gottardo 10, Lugano, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
Distribution
US distribution to CA & NY.
States: California New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0107-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.