Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 25, 2025
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.
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Diagnostica Stago, Inc. recalled STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solutio… - a moderate-severity action.
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solutio… was recalled by Diagnostica Stago, Inc. in June 25, 2025. Reason: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimat…. Check the official notice for the remedy. Verify recall #Z-1993-2025 with the FDA Devices before acting.
The recall
Diagnostica Stago, Inc. issued this moderate-severity FDA Devices recall-Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimat….
- Moderate
- severity level
- Class II
- classification
- June 25, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1993-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1993-2025) was formally reported on June 25, 2025, with the manufacturer initiating the action on May 21, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Diagnostica Stago, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 939 US ( 2,810 total worldwide).
The documented reason for this recall is: Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1% Distribution data in the federal record shows the product reached: 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 Territo…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
939 US ( 2,810 total worldwide)
Related Recalls
6
3 from same agency
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.
Reason for recall
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1993-2025 |
| Date reported | June 25, 2025 |
| Date initiated | May 21, 2025 |
| Recalling firm | Diagnostica Stago, Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1993-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Diagnostica Stago, Inc.. Units affected: 939 US ( 2,810 total worldwide).
Why was this product recalled? ▼
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1993-2025.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1993-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 25, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.