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Procalcitonin (PCT) Bi-Level Controls
STANBIO LABORATORY, L.P. · Model 2320-203 · UDI-DI 00657498001974
PTF
Prescription
4
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities
Description
The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in examining the accuracy and precision of the quantitative Stanbio Procalcitonin (PCT) LiquiColor® Assay.
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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