FlexLab X System (Inpeco) – Sample Integrity Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Brand
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
Lot Codes / Batch Numbers
PN: FLX-056-40, UDI: 07640172344002: Serial No. FXX.0015.
Products Sold
PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
Inpeco S.A. Via San Gottardo 10 Lugano Switzerland is recalling FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic due to The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees received an Urgent Medical Device Recall notification via email dated 9/3/25. The notification instructs consignees to not rely on HIL functionality for clinical decision making or to flag potentially erroneous samples. HIL functionality must be discontinued and cannot be disabled by users. Inspeco must send an Inspeco Servicer to consignee locations to disable HIL functionality. Inspeco will contact consingnees to schedule this service. Consignees are to forward the provided notification to those whom it might concern. Consignees with questions can contact Regulatory Affairs via email at regulatory.affairs@inspeco.com or Inspeco Service Team via email at service.NA@inspeco.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NY
Page updated: Jan 10, 2026