FDA recall record · openFDA

Diagnostica Stago, Inc.

12 FDA recalls on record (2023–2026) — 12 device. 12 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. 4

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened c 3

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

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. 1

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements th 1

Recalls

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The Class II 2026-02-05 Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Pro Class II 2026-02-04 STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, S Class II 2025-07-21 STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent Class II 2025-05-21 Product: STA Liatest D-Di; REF: 00515; Class II 2025-09-12 STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop a Class II 2025-07-21 STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, Class II 2025-07-21 Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection i Class II 2025-12-15 STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers o Class II 2025-07-21 STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 Class II 2023-03-22 STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 Class II 2023-03-22 STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59 Class II 2023-03-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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