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Diagnostica Stago, Inc. FDA Recalls
13 recalls on file across devices, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor defiClass IIJul 29, 2026A positive drift in QC values within the reagent's stated 4- |
| Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vClass IIFeb 5, 2026After receiving customer complaints, investigations confirme |
| Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 ProClass IIFeb 4, 2026The potential of out-of-range results and an underestimation |
| Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection iClass IIDec 15, 2025Potential for defect for Asserachrom HPIA lot 271288, which |
| Product: STA Liatest D-Di; REF: 00515;Class IISep 12, 2025A potential risk of underestimation of D-Dimer (D-Di) levels |
| STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers oClass IIJul 21, 2025Potential for contamination of STA-LIQUID ANTI-Xa by Stago F |
| STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, Class IIJul 21, 2025Potential for contamination of STA-LIQUID ANTI-Xa by Stago F |
| STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, SClass IIJul 21, 2025Potential for contamination of STA-LIQUID ANTI-Xa by Stago F |
| STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop aClass IIJul 21, 2025Potential for contamination of STA-LIQUID ANTI-Xa by Stago F |
| STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluentClass IIMay 21, 2025Potential for shorter clotting times in clotting tests which |
| STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612Class IIMar 22, 2023An internal investigation identified a bug in this firmware |
| STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59Class IIMar 22, 2023An internal investigation identified a bug in this firmware |
| STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612Class IIMar 22, 2023An internal investigation identified a bug in this firmware |