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Berichrom® Heparin UF Control 1

Siemens Healthcare Diagnostics Products GmbH · Model 10445985 · UDI-DI 00842768006821

GIZ
1
510(k) clearances
0
Adverse events
1
Recalls
16
Facilities

Description

For use as a low level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin

Recalls

DateFirmReason
2019-11-18Diagnostica Stago, Inc.A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for fact

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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.