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Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
FDA product code PTF · Class 2 · Microbiology
12
Registered devices
0
Adverse events
1
Recalls
4
510(k) clearances
Devices with this code
Atellica IM BRAHMS PCT — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHAccess PCT — IMMUNOTECHProcalcitonin (PCT) Calibrators — STANBIO LABORATORY, L.P.Procalcitonin LiquiColor — STANBIO LABORATORY, L.P.ARCHITECT — Abbott GmbHAccess PCT — Beckman Coulter, Inc.ARCHITECT — Abbott GmbHAlinity — Abbott Ireland DiagnosticsDiaSys Procalcitonin FS — DiaSys Diagnostic Systems GmbHARCHITECT — Abbott GmbHProcalcitonin (PCT) Bi-Level Controls — STANBIO LABORATORY, L.P.
Recent 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. |
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