FlexLab X Potassium Test System Has Unevaluated Sample Analysis Function
The FlexLab X in vitro diagnostic system includes a Sample Integrity Module function for detecting hemolysis, icterus, and lipemia in blood samples that was not evaluated by the FDA. Its use may produce erroneous test results or delays in patient results.
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 a Class II medical device with a function that has not been FDA-evaluated and may produce erroneous diagnostic results or delays in patient results. No adverse events have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High), and the absence of reported illness with a theoretical hazard caps the score at 3.
Plain-English summary
The FlexLab X (FXX) System is an in vitro diagnostic device used for potassium testing. The device includes a Sample Integrity Module (SIM) that contains a function to determine hemolysis, icterus, and lipemia (HIL) in blood samples.
The Sample Integrity Module's HIL detection function has not been evaluated by the FDA for safety and effectiveness. Because this function lacks FDA evaluation, its use may result in erroneous test results or delays in providing patient results.
The affected devices are FlexLab X systems distributed in the United States, specifically to locations in California and New York. The recalled unit has part number FLX-056-40, UDI 07640172344002, and serial number FXX.0015.
Healthcare facilities using this device should review the FDA recall notice and contact the manufacturer, Inpeco S.A., for additional information and guidance on product use or replacement.
The recalled product
- Product
- FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
- Manufacturer
- Inpeco S.A.
- Hazard
- diagnostic-error
- delayed-results
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:
- CA
- NY
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