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Diagnostica Stago, Inc. recalls STA UNICALIBRATOR (ref. 00675)
Recalled January 1, 2020 · FDA recall Z-0737-2020 · Diagnostica Stago
Hazard
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 factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results. · FDA Class II
Units
5,498
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Description
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 factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
Product
STA UNICALIBRATOR (ref. 00675)
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →