FDA Device recall Z-1699-2020
STA - Deficient VIII, Product Code: 00725
- FDA Device
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of STA - Deficient VIII, Product Code: 00725 by Diagnostica Stago, citing 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 report….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1699-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-04 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
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, 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
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
Identifiers
| code_info | All lots This cleaning sequence has been implemented in the following available software versions. Customers not po…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2020%22
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