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INNOVANCE Anti-Xa

Siemens Healthcare Diagnostics Products GmbH · Model 10873681 · UDI-DI 00630414240404

QLU
1
510(k) clearances
0
Adverse events
1
Recalls
3
Facilities

Description

In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma.

Recalls

DateFirmReason
2021-08-25Instrumentation LaboratoryLabeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

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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.