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CRYOcheck™ Reference Control Normal

Precision Biologic Inc · Model RCN-05 · UDI-DI 00843876000053

GIZ
1
510(k) clearances
0
Adverse events
1
Recalls
15
Facilities

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.