STA - Owren Koller recall
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…
Why was STA - Owren Koller recalled?
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
- 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…
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 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 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.
- Recall date
- June 25, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)