Z-1993-2025Class II

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a...

Name: Z-1993-2025 STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a...
Creator: Diagnostica Stago, Inc.
Published: 2025-05-21
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2025-05-21 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of 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... on 2025-05-21. FDA classified it as Class II and gives the reason as "Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1993-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-21
Posted: 2025-06-18
Recalling firm: 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.
Product code: PPM General Purpose Reagent
Reason for recall: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1993-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1993-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-18

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)