Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk
Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (falsely increased factor VIII levels) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Diagnostica Stago, Inc. is recalling 3,225 units of STA-Deficient VIII, Product Code 00725. This immuno-depleted human plasma is intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms. The product was distributed nationwide.
The recall is due to a risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments. This contamination may shorten clotting times, causing factor VIII levels to be reported as falsely increased.
Customers using the affected software versions should contact Stago Field Support for upgrades to the specified software levels to implement the necessary cleaning sequence.
The recalled product
- 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, 5899
- Manufacturer
- Diagnostica Stago, Inc.
- Affected units
- 3,225
Distribution
Distributed nationwide across the United States.
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