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Diagnostica Stago, Inc. recalls STA SYSTEM CONROL N + P (ref. 00678)
Recalled January 1, 2020 · FDA recall Z-0738-2020 · 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
5,437
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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 SYSTEM CONROL N + P (ref. 00678)
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →