Reported Apr 22, 2020 · Terminated
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in…
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- STA - Deficient VIII
- Product Code00725. 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
5898958990 (B) STA-R Evolution
- Product Codes
589865898758988 (C) STA Compact Max
- Product Codes
5902659027 (D) STA Compact
- Product Codes
5897858979
- Lot codes and dates
- All lots This cleaning sequence has been implemented in the following available software versions. Customers not possessing these software levels will be upgraded
- by Stago Field Support personnelSTA-R¿
- Max (all serial numbers)Software version 4.05.04 or higher, and Methodology Update (MU) to enhance database version MS215. STA-R¿ Evolution (serial
- numbers higher than 8012756)Software version 3.04.09 or higher STA¿
- Compact Max (all serial numbers)Software version 110.05 or higher
- Amount recalled
- 3,225 units
Where it was sold
- 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
This product could cause temporary or reversible health problems — stop using it.
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