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DiaSys Procalcitonin FS
DiaSys Diagnostic Systems GmbH · Model 173189943018 · UDI-DI 04051839013668
PTF
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
8
Facilities
Description
Diagnostic reagent for quantitative in vitro determination of procalcitonin (PCT) in human serum or lithium heparin plasma
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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