Z-0106-2026Class II

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

Name: Z-0106-2026 FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Creator: Inpeco S.A.
Published: 2025-09-03
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2025-09-03 / Open, Classified

FDA source

Inpeco S.A. began a recall of FlexLab (FLX) System. Potassium Test System. in vitro diagnostic on 2025-09-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0106-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-03
Posted: 2025-10-09
Recalling firm: Inpeco S.p.A.
Product: FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Product code: CEM Electrode, Ion Specific, Potassium
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 root cause: No Marketing Application
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].
Quantity in commerce: 8 units
Distribution: US distribution to CA & NY.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0106-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0106-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09
Z-0107-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-09

Product code CEM

K121012Class IIFlexlab 3.6, Accelerator A3600Inpeco S.P.A. / cleared 2012-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)