Diagnostica Stago, Inc. recalls STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in…

Recall date

March 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1699-2020

FDA classification

Class II

Brand / firm

Diagnostica Stago, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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