STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent fo
FDA device recall Z-1993-2025 · posted 2025-06-18 · Open, Classified
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
- Action taken
- Diagnostica Stago, Inc. notified consignees on 05/21/2025 via email. Consignees were instructed to review inventory for any affected units, stop using the affected lot and destroy it, and complete and return the acknowledgement form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PPM
- Quantity affected
- 939 US ( 2,810 total worldwide)
- Distribution
- The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distribut
- Date initiated
- 2025-05-21
- Date posted
- 2025-06-18
- Location
- Parsippany, NJ
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