Lower riskMedical device recall · FDA · Published September 3, 2025
Inpeco FlexLab X Potassium Test System Recall: Risk of Erroneous Results
Inpeco recalls FlexLab X Potassium Test System due to unverified safety of blood test results. This may cause inaccurate patient results or delays in treatment.
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.
Take action
Contact the company
📍Recalling firmInpeco S.A.Via San Gottardo 10 · Lugano, Switzerland
“Inpeco FlexLab X Potassium Test System Recall: Risk of Erroneous Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51485-inpeco-flexlab-x-potassium-test-system-recall-risk-of-erroneous. Based on FDA recall #Z-0107-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0107-2026%22&limit=1).
The FDA announced on 2025-09-03 that Inpeco S.A. is recalling the FlexLab X (FXX) System Potassium Test System in vitro diagnostic device. The recall addresses an unaudited function that may cause erroneous or delayed patient results.
How to tell if you have it
Brand: Inpeco
Product: FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Part Number: FLX-056-40
UDI: 07640172344002
Serial No.: FXX.0015
The hazard
The FlexLab X System Sample Integrity Module (SIM) includes a function to determine hemolysis, icterus, and lipemia in blood samples that has not been evaluated for safety and effectiveness by the FDA. According to the FDA, this may cause an increase in erroneous results or a delay in patient results.
Context
GovInfoNow's records show Inpeco S.A. has 13 other recalls on record since 2018-02-13. Other recent recalls of similar products include Medica Capillary Tubes Recall (2025-12-31), Siemens Atellica CH A1c_E Test Recall (2026-06-08), and Vivoo Test Strips Recall (2025-11-22).
How to tell if you have this one
Check for the FlexLab X (FXX) System with model number FLX-056-40 and serial number FXX.0015. The product was sold with UDI 07640172344002.
Brand
Inpeco
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US distribution to CA & NY.
Recall number
Product, codes & lots
Quantity
Z-0106-2026
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic; 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.
8 units
Z-0107-2026
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic; PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
1 unit
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number FLX-056-40 and serial number FXX.0015 to confirm if your system is affected.
Where it went and when
Where it was distributed
Distributed in California and New York.
Listed by the agency
Not listed
FDA distribution: “US distribution to CA & NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, New York.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0107-2026 (September 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0107-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.