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Procalcitonin (PCT) Calibrators

STANBIO LABORATORY, L.P. · Model 2310-601 · UDI-DI 00657498001967

PTF Prescription
4
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities

Description

The Stanbio Procalcitonin (PCT) Calibrator Set is intended for use in the calibration of the quantitative Stanbio PCT LiquiColor® Assay.

Recalls

DateFirmReason
2025-01-02Beckman 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.