HIGH

Inpeco S.A. Recalls FlexLab X System Over Erroneous Test Results

Inpeco S.A. recalled one unit of the FlexLab X (FXX) System on September 3, 2025. The recall affects the Sample Integrity Module, which has not been FDA evaluated for safety. This may cause erroneous results or delays in patient testing.

Quick Facts at a Glance

Recall Date
September 3, 2025
Hazard Level
HIGH
Brand
Inpeco S.A.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
2 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Inpeco S.A. or your healthcare provider for instructions. Notification method: E-Mail

Product Details

The recalled product is the FlexLab X (FXX) System, Model PN: FLX-056-40 and UDI: 07640172344002, Serial No. FXX.0015. It was distributed in California and New York.

The Hazard

The Sample Integrity Module (SIM) of the FlexLab X System determines hemolysis, icterus, and lipemia in blood samples. The FDA has not evaluated this function for safety and effectiveness, potentially leading to erroneous test results.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to the potential for erroneous results.

What to Do

Stop using the FlexLab X System immediately. Follow the recall instructions provided by Inpeco S.A. and contact your healthcare provider for guidance.

Contact Information

For further assistance, contact Inpeco S.A. via email. Visit the recall notice at the FDA website for more information.

Key Facts

  • Recall date: September 3, 2025
  • High hazard level due to potential erroneous test results
  • One unit recalled
  • Contact Inpeco S.A. for instructions
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeDiagnostic System
Sold At
Multiple Retailers

Product Details

Model Numbers
PN: FLX-056-40
UDI: 07640172344002: Serial No. FXX.0015.
Affected States
CA, NY
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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