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Diagnostica Stago, Inc. recalls STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in
Recalled April 22, 2020 · FDA recall Z-1699-2020 · Diagnostica Stago
Hazard
A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased · FDA Class II
Units
3,225 units
Sold at
Nationwide
Description
A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
Product
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →