Diagnostica Stago, Inc.
FDA Regulatory Profile
Diagnostica Stago, Inc. appears in FDA public data with 26 recalls, 21 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1585-2026, Class II) was initiated on February 5, 2026. Its most recent 510(k) clearance was granted on April 27, 2026.
Summary
- Total Recalls
- 26
- 510(k) Clearances
- 21
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1585-2026 | Class II | Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ | February 5, 2026 |
| Z-1491-2026 | Class II | Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Numb | February 4, 2026 |
| Z-1084-2026 | Class II | Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qua | December 15, 2025 |
| Z-0205-2026 | Class II | Product: STA Liatest D-Di; REF: 00515; | September 12, 2025 |
| Z-2475-2025 | Class II | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended | July 21, 2025 |
| Z-2474-2025 | Class II | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended f | July 21, 2025 |
| Z-2476-2025 | Class II | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use | July 21, 2025 |
| Z-2473-2025 | Class II | STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully | July 21, 2025 |
| Z-1993-2025 | Class II | STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended | May 21, 2025 |
| Z-1576-2023 | Class II | STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 | March 22, 2023 |
| Z-1575-2023 | Class II | STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference | March 22, 2023 |
| Z-1577-2023 | Class II | STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 | March 22, 2023 |
| Z-1699-2020 | Class II | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma | March 4, 2020 |
| Z-0737-2020 | Class II | STA UNICALIBRATOR (ref. 00675) | November 18, 2019 |
| Z-0738-2020 | Class II | STA SYSTEM CONROL N + P (ref. 00678) | November 18, 2019 |
| Z-0611-2019 | Class II | Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems desig | November 14, 2018 |
| Z-0610-2019 | Class II | Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designe | November 14, 2018 |
| Z-2993-2018 | Class II | Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of t | July 24, 2018 |
| Z-2994-2018 | Class II | Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the pro | July 24, 2018 |
| Z-1069-2018 | Class II | STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of th | October 25, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253658 | STA Satellite Max® | April 27, 2026 |
| K212183 | STA R Max 3, STA Compact Max 3 | June 7, 2023 |
| K211485 | STA- NeoPTimal | December 23, 2022 |
| K162227 | STA® - Liatest® D-Di | December 10, 2016 |
| K151867 | STA R MAX | August 7, 2015 |
| K141144 | STA LIATEST D-DI | September 3, 2014 |
| K120014 | STA- COAG CONTROL (N+ABN) PLUS | March 14, 2013 |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | October 26, 2011 |
| K092937 | STA-HYBRID HEP CALIBRATOR | August 2, 2010 |
| K092170 | STA LIATEST FREE PS | December 22, 2009 |
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | December 22, 2009 |
| K092113 | STA - FREE PS CALIBRATOR | November 13, 2009 |
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | December 12, 2008 |
| K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | October 10, 2008 |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | December 6, 2006 |
| K061803 | STA - CONTROL LA 1+2 | July 28, 2006 |
| K053111 | STA-CEPHASCREEN KIT | May 4, 2006 |
| K010963 | STA-LIATEST FREE PROTEIN S TEST KIT | June 6, 2001 |
| K010350 | STA -CALIBRATOR HBPM/LMWH KIT | April 9, 2001 |
| K010324 | STA-QUALITY HBPM/LMWH KIT | April 9, 2001 |