Diagnostic potassium test system function lacks FDA safety evaluation
Inpeco's FlexLab potassium test system includes a sample evaluation function that the FDA has not assessed for safety and effectiveness. This unevaluated function may produce incorrect test results or delays in patient care.
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is theoretical risk of erroneous or delayed test results from an unevaluated diagnostic function, meeting the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FlexLab System is an in vitro diagnostic device used to test potassium levels in blood samples. It is manufactured by Inpeco S.A. and includes a Sample Integrity Module (SIM) with a function to assess hemolysis, icterus, and lipemia (HIL)—conditions in blood samples that can affect diagnostic accuracy.
The HIL evaluation function in the Sample Integrity Module has not been evaluated by the FDA for safety and effectiveness. This unevaluated function may cause an increase in erroneous test results or may delay the provision of patient results.
Eight units of the affected FlexLab System were distributed to healthcare facilities in California and New York. The affected serial numbers are FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, and FLX.0222.
The recalled product
- Product
- FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
- Manufacturer
- Inpeco S.A.
- Hazard
- erroneous-test-results
- delayed-test-results
- unevaluated-function
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 (10)
- 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.
Distribution
Distributed in 2 states:
- CA
- NY
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