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Procalcitonin LiquiColor
STANBIO LABORATORY, L.P. · Model 2300-060 · UDI-DI 00657498001950
PTF
Prescription
4
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities
Description
Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determination of PCT in human serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. This test is used in conjunction with other laboratory tests and clinical examinations to aid in the risk assessment of ill patients on their initial hospital admission for the potential development of sepsis and/ or septic shock.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-02 | Beckman Coulter Inc. | Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results |
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