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

Class I - Dangerous

🏥 Medical Devices Recalled: March 4, 2020 Diagnostica Stago Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
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 personnel: STA-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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Diagnostica Stago, Inc.
Reason for Recall:: 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
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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 personnel: STA-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.