FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
FDA Recall Z-0107-2026 · Posted 2025-10-09
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Recalling FirmInpeco S.A.
Recall StatusOpen, Classified
Product CodeCEM
Date Initiated2025-09-03
Product Quantity1 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.
Firm Action
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 [email protected] or Inspeco Service Team via email at [email protected].
Root Cause
No Marketing Application
Distribution Pattern
US distribution to CA & NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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