Diagnostica Stago, Inc.

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
20
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1491-2026Class IIBrand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog NumbFebruary 4, 2026
Z-1084-2026Class IIAsserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the quaDecember 15, 2025
Z-0205-2026Class IIProduct: STA Liatest D-Di; REF: 00515;September 12, 2025
Z-2474-2025Class IISTA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended fJuly 21, 2025
Z-2473-2025Class IISTA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully July 21, 2025
Z-2475-2025Class IISTA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended July 21, 2025
Z-2476-2025Class IISTA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use July 21, 2025
Z-1993-2025Class IISTA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended May 21, 2025
Z-1575-2023Class IISTA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference March 22, 2023
Z-1577-2023Class IISTA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612March 22, 2023
Z-1576-2023Class IISTA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612March 22, 2023
Z-1699-2020Class IISTA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma March 4, 2020
Z-0738-2020Class IISTA SYSTEM CONROL N + P (ref. 00678)November 18, 2019
Z-0737-2020Class IISTA UNICALIBRATOR (ref. 00675)November 18, 2019
Z-0610-2019Class IIStaclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designeNovember 14, 2018
Z-0611-2019Class IIStaclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems desigNovember 14, 2018
Z-2994-2018Class IIDiagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the proJuly 24, 2018
Z-2993-2018Class IIDiagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of tJuly 24, 2018
Z-1069-2018Class IISTA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of thOctober 25, 2017
Z-1066-2018Class IINeoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the protOctober 25, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K212183STA R Max 3, STA Compact Max 3June 7, 2023
K211485STA- NeoPTimalDecember 23, 2022
K162227STA® - Liatest® D-DiDecember 10, 2016
K151867STA R MAXAugust 7, 2015
K141144STA LIATEST D-DISeptember 3, 2014
K120014STA- COAG CONTROL (N+ABN) PLUSMarch 14, 2013
K111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHOctober 26, 2011
K092937STA-HYBRID HEP CALIBRATORAugust 2, 2010
K093167STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZERDecember 22, 2009
K092170STA LIATEST FREE PSDecember 22, 2009
K092113STA - FREE PS CALIBRATORNovember 13, 2009
K082248STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZERDecember 12, 2008
K082675STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZEROctober 10, 2008
K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDecember 6, 2006
K061803STA - CONTROL LA 1+2July 28, 2006
K053111STA-CEPHASCREEN KITMay 4, 2006
K010963STA-LIATEST FREE PROTEIN S TEST KITJune 6, 2001
K010324STA-QUALITY HBPM/LMWH KITApril 9, 2001
K010350STA -CALIBRATOR HBPM/LMWH KITApril 9, 2001
K003767ASSERACHROM HPIA TEST KITFebruary 12, 2001