HIGH

Inpeco S.A. Recalls Potassium Test System Over Safety Concerns

Inpeco S.A. recalled eight units of its FlexLab (FLX) Potassium Test System on September 3, 2025. The system's Sample Integrity Module may produce erroneous results due to unverified functions. Healthcare providers must stop using the device immediately and follow the manufacturer's instructions.

Quick Facts at a Glance

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

Hazard Information

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.

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 products include the FlexLab (FLX) System with model numbers 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, and FLX.0222. These devices were distributed in California and New York. No pricing information is available.

The Hazard

The Sample Integrity Module in the FlexLab (FLX) System determines hemolysis, icterus, and lipemia in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, potentially leading to erroneous results or delays in patient results.

Reported Incidents

No specific incidents, injuries, or deaths have been reported related to this recall. The potential for erroneous results poses a high risk to patient safety.

What to Do

Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Inpeco S.A. or consult your healthcare provider for further actions.

Contact Information

For more information, contact Inpeco S.A. via email. Visit the recall notification page for further details.

Key Facts

  • Recall date: September 3, 2025
  • Report date: October 15, 2025
  • Quantity recalled: 8 units
  • Distribution: California and New York
  • Classification: Class II
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 TypePotassium Test System
Sold At
Unknown

Product Details

Model Numbers
PN: FLX-056-01
FLX-056-11
UDI: 07640172340004: Serial No. FLX.0204
FLX.0205
FLX.0209
+5 more
Affected States
CA, NY
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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