Recall Z-1699-2020 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Diagnostica Stago, Inc.
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
| Date | Mar 4, 2020 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | Stago notified on 3/4/20 end users of the risks to factor VIII tests in writing. Letters issued via email, US mail, and/or UPS overnight mail. Letter states reason for recall, health risk and action to take: To remove this cross-contamination risk, a special pre-wash has been developed for the concerned Stago methodology. It involves special washing of needle 1 before every factor VIII assay in order to eliminate any residual quantities of Emicizumab. This cleaning sequence has been implemented in the stated available software versions. Customers not possessing these software levels will be |
| Quantity | 3,225 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892859 | THE STAGO VIII DEFICIENT PLASMA KIT American Bioproducts Co., Jun 23, 1989 |