The Recall Desk
HighFDA (Devices)·Z-0107-2026·Announced 2025-10-15

FlexLab X system recalled over unevaluated blood sample integrity function

Inpeco is recalling one FlexLab X system because the Sample Integrity Module's hemolysis, icterus and lipemia function has not been evaluated by the FDA.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states the function may increase erroneous results, which can misdirect care, and no injuries are reported.

Plain-English summary

The FlexLab X (FXX) System, a potassium test system used as an in vitro diagnostic, is being recalled.

The FlexLab X System Sample Integrity Module (SIM) includes a function that determines hemolysis, icterus and lipemia (HIL) in blood samples. That 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.

The recall covers one unit, part number FLX-056-40, UDI 07640172344002, serial number FXX.0015. The product was distributed to California and New York. The FDA has classified the action as Class II.

The laboratory running the affected serial number should follow Inpeco's instructions regarding use of the HIL function.

The recalled product

Product
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory automation
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • PN: FLX-056-40
  • UDI: 07640172344002: Serial No. FXX.0015.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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