Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STA - Deficient VIII Recalled by Diagnostica Stago, Inc. Due to A risk of sample-to-sample cross-contamination of Emicizumab for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.
Affected Products
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
Quantity: 3,225 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Diagnostica Stago, Inc.
Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report