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Access PCT
Beckman Coulter, Inc. · Model C53987 · UDI-DI 15099590736002
PTF
Prescription
4
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities
Description
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and 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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