# FDA recall Z-1993-2025

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2025-05-21.

## 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 for recall

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

## 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.

## Key facts

- **Recall number:** Z-1993-2025
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-21
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2025

## Citation

> AI Analytics. FDA recall Z-1993-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1993-2025. Source: US FDA. Licensed CC0.

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