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Atellica IM BRAHMS PCT

Siemens Healthcare Diagnostics Inc. · Model 11202699 · UDI-DI 00630414246550

PRIPTFPMT
1
510(k) clearances
214
Adverse events
1
Recalls
12
Facilities

Description

Procalcitonin (PCT) Atellica IM - RGT 100T

Recalls

DateFirmReason
2021-09-22bioMerieux, Inc.bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.