Laboratory automation systems recalled over unevaluated sample integrity function
Inpeco is recalling eight FlexLab systems 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 (FLX) System, a potassium test system used as an in vitro diagnostic, is being recalled.
The FlexLab 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 eight units, part numbers FLX-056-01 and FLX-056-11, UDI 07640172340004, with serial numbers including FLX.0204, FLX.0205, FLX.0209, FLX.0210 and FLX.0216. The product was distributed to California and New York. The FDA has classified the action as Class II.
Laboratories running affected serial numbers should follow Inpeco's instructions regarding use of the HIL function.
The recalled product
- Product
- FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
- Manufacturer
- Inpeco S.A.
- Hazard
- unevaluated-function
- erroneous-results
- in-vitro-diagnostic
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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