PlainRecordsSTA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a…
- Reason
- Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
- Status
- Ongoing
- 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…
- Enforcement report date
- June 25, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Diagnostica Stago, Inc.
- 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%
- Distribution pattern
- 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.
- Quantity
- 939 US ( 2,810 total worldwide)
- Codes and lots
- UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
- Recall started
- May 21, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- General Purpose Reagent
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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 number
- Z-1993-2025
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%”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., FDA enforcement report, 2025-06-25. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: General Purpose Reagent
Distributed in (FDA's record): Puerto Rico
This recall among the others
- FDA's enforcement report came 35 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Diagnostica Stago: 1 other recall or notice on this site in the three years before this one (from June 26, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1993-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1993-2025, June 25, 2025. "STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a." PlainRecords, https://plainrecords.com/recall/device/z-1993-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections