Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Diagnostica Stago with 27 device recalls and 25 510(k) clearances. The most recent is a 510(k) clearance dated Sep 24, 2026: STA® - Liquid Anti-Xa.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 24, 2026 | STA® - Liquid Anti-XaK260214 · KFF | 510(k) clearances |
| Jul 29, 2026 | STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency testClass II · A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified | Device recalls |
| Apr 27, 2026 | STA Satellite Max®K253658 · JPA | 510(k) clearances |
| Feb 5, 2026 | Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. TheClass II · After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements th | Device recalls |
| Feb 4, 2026 | Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: ThClass II · The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The | Device recalls |
| Dec 15, 2025 | Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum ofClass II · Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce nega | Device recalls |
| Sep 12, 2025 | Product: STA Liatest D-Di; REF: 00515;Class II · A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. | Device recalls |
| Jul 21, 2025 | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA SClass II · Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Device recalls |
| Jul 21, 2025 | STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of sClass II · Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Device recalls |
| Jul 21, 2025 | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Class II · Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Device recalls |
| Jun 7, 2023 | STA R Max 3, STA Compact Max 3K212183 · JPA | 510(k) clearances |
| Dec 23, 2022 | STA- NeoPTimalK211485 · GJS | 510(k) clearances |
| Dec 10, 2016 | STA® - Liatest® D-DiK162227 · DAP | 510(k) clearances |
| Aug 7, 2015 | STA R MAXK151867 · JPA | 510(k) clearances |
| Sep 3, 2014 | STA LIATEST D-DIK141144 · DAP | 510(k) clearances |
| Mar 14, 2013 | STA- COAG CONTROL (N+ABN) PLUSK120014 · GGN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
