Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solut…
Reason for recall
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 familiesSTAAffected lot270902
What the firm is doing
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.
DistributionShow detailsHide
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 Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1993-2025
- FDA device classification · PPMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 864.4010The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Diagnostica Stago, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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