FDA Device recall Z-1993-2025
STA - Owren Koller
- FDA Device
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of STA - Owren Koller by Diagnostica Stago, citing potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1993-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-21 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diagnostica Stago |
| Distribution | PR |
Product
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
Reason
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Identifiers
| code_info | UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Diagnostica Stago
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FDA Device · Class II · 2026-09-09 · Diagnostica Stago - Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic
FDA Device · Class II · 2026-03-25 · Diagnostica Stago - Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
FDA Device · Class II · 2026-03-11 · Diagnostica Stago - Asserachrom HPIA. Model/Catalog Number: 00615
FDA Device · Class II · 2026-01-21 · Diagnostica Stago - Product: STA Liatest D-Di
FDA Device · Class II · 2025-10-22 · Diagnostica Stago
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.