FlexLab X recall
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Why was FlexLab X recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
- Product
- FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
- Recalling firm
- Inpeco S.A.
- Quantity
- 1 unit
- Distribution
- US distribution to CA & NY.
- Recall date
- October 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)