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U.S. Department of Health and Human Services

Class 2 Device Recall FlexLab System

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 Class 2 Device Recall FlexLab Systemsee related information
Date Initiated by FirmSeptember 03, 2025
Date PostedOctober 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0106-2026
Recall Event ID 97565
510(K)NumberK121012 
Product Classification Electrode, ion specific, potassium - Product Code CEM
ProductFlexLab (FLX) System. Potassium Test System. in vitro diagnostic
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.
FEI Number 3010825766
Recalling Firm/
Manufacturer		 Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
Manufacturer 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.
FDA Determined
Cause 2		No Marketing Application
ActionConsignees 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.
Quantity in Commerce8 units
DistributionUS distribution to CA & NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CEM
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