STA - Owren Koller. Model/Catalog Number: 00360 recallZ-1993-2025 · Diagnostica Stago, Inc. · initiated May 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
FDA root cause category: Under Investigation by firm
What the company 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.
Recall details
- Recall number
- Z-1993-2025
- Status
- Open, Classified
- Initiated by the company
- May 21, 2025
- Posted by the FDA
- Jun 18, 2025
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 939 US ( 2,810 total worldwide)
- Product code
- PPM
- 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 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.
Product description
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.
Code information (models, lots, serial numbers)
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- STA® - Owren-Koller 00360Diagnostica Stago · General purpose reagent1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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