FlexLab (FLX) System. Potassium Test System. in vitro… recallZ-0106-2026 · Inpeco S.A. · initiated Sep 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Inpeco S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: No Marketing Application
What the company is doing
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].
Recall details
- Recall number
- Z-0106-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 3, 2025
- Posted by the FDA
- Oct 9, 2025
- Recalling firm
- Inpeco S.A.
- Quantity
- 8 units
- Product code
- CEM
- FDA submissions
- K121012
- Distribution
- US distribution to CA & NY.
Product description
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FlexLab FLXInpeco SA · Electrode, Ion Specific, Potassium8 recalls17 reports
Other devices under the same FDA submission
3 devices cleared under K121012 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Aptio Automation AP2Inpeco SA · Electrode, Ion Specific, Potassium5 recalls6 deaths16 reports
- Accelerator a3600 ACPInpeco SA · Electrode, Ion Specific, Potassium5 recalls13 reports
- FlexLab X FXXInpeco SA · Electrode, Ion Specific, Potassium2 recalls2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97565).
- Z-0107-2026 · Open, ClassifiedFlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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