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Atellica IM PCT QC

Siemens Healthcare Diagnostics Inc. · Model 10995652 · UDI-DI 00630414599700

NTM
3
510(k) clearances
8
Adverse events
2
Recalls
9
Facilities

Description

Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 5.0mL

Recalls

DateFirmReason
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2014-04-10Siemens Healthcare Diagnostics, IncSamples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

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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.