Diagnostica Stago, Inc. recalls
Every recall we track for Diagnostica Stago, Inc. — 24 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Diagnostica Stago, Inc. peaked in 2025 (7); 24 since 2017.
All FDA recall records for Diagnostica Stago, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 3 | 0 | 4 |
| 2018 | 0 | 0 | 4 | 0 | 4 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 7 | 0 | 7 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
What to do if you have a recalled Diagnostica Stago, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Diagnostica Stago, Inc. recalls
13 shown- Lower riskMedical device
Diagnostica Stago, Inc. recalls STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor
Diagnostica Stago recalls STA Staclot Protein S reagent lot 273074 due to potential QC value drift during 4-hour stability period. Affected units may give inaccurate test results.
Diagnostica StagoJul 29, 2026 - Lower riskMedical device
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in
Stago recalls STA Liatest D-Di kits with REF 00515 due to potential positive bias in D-dimer measurements, which could lead to inaccurate blood test results.
StagoFeb 5, 2026 - Lower riskMedical device
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516
Diagnostica Stago recalls STA Liatest Free Protein S kits (model 00516) due to potential out-of-range results and underestimation of free protein S levels in patient plasmas. Affected kits may give incorrect readings for normal-range values.
StagoFeb 4, 2026 - Lower riskMedical device
Diagnostica Stago, Inc. recalls Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in
Diagnostica Stago recalls Asserachrom HPIA kit model 00615 with lot 271288 due to potential false negative results in heparin-induced thrombocytopenia testing. Affected kits may not detect anti-heparin-platelet factor 4 antibodies correctly.
Diagnostica StagoDec 15, 2025 - Lower riskMedical device
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;
Diagnostica Stago recalls STA Liatest D-Di test kits with specific lot numbers due to potential underestimation of D-Dimer levels. Affected users should check their lot numbers and contact the manufacturer for guidance.
Diagnostica StagoSep 12, 2025 - Lower riskMedical device
Diagnostica Stago, Inc. recalls STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA
Stago recalls STA-Liquid Anti-Xa 4 kits (model 00311US) due to potential contamination with fibrinogen reagents in heparin tests. Affected users should contact Stago for details.
StagoJul 21, 2025 - Lower riskMedical device
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent
Diagnostica Stago recalls Owren Koller buffer solution (model 00360) due to potential shorter clotting times in tests, which could overestimate results by up to 1%. Affected units sold with specific UDI and lot numbers.
Diagnostica StagoMay 21, 2025 - Lower riskMedical device
Diagnostica Stago, Inc. recalls STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Diagnostica Stago recalls STA Compact Automated Multi-Parametric Analyzer with firmware bug causing inconsistent coagulation test results. Affected units have reference numbers 58602 or 58612.
StagoMar 22, 2023 - Lower riskMedical device
Diagnostica Stago, Inc. recalls STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in
Stago recalls STA Deficient VIII product code 00725 due to risk of false high factor VIII results from cross-contamination. Affected units include specific STA-R and STA Compact analyzers with listed product codes and software versions.
StagoMar 4, 2020 - Lower riskMedical device
Diagnostica Stago, Inc. recalls STA SYSTEM CONROL N + P (ref. 00678)
Diagnostica Stago recalls STA System Control N+P (ref. 00678) due to positive bias in factor VIII/IX testing compared to international standards. Affected lots may cause inaccurate blood test results.
Diagnostica StagoNov 18, 2019 - Lower riskMedical device
Diagnostica Stago, Inc. recalls Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative
Diagnostica Stago recalls Staclot LA 20 test kits with reported shortened results. Affected lots may cause inaccurate lupus anticoagulant testing.
Diagnostica StagoNov 14, 2018 - Lower riskMedical device
Diagnostica Stago, Inc. recalls Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT)
Diagnostica Stago recalls STA Noplastine CI 10ml vials for potential prothrombin time measurement errors. Affected units have QC values outside assigned ranges, requiring immediate action.
Diagnostica StagoJul 24, 2018 - Use cautionMedical device
Diagnostica Stago, Inc. recalls STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago recalls Neoplastine Cl Plus reagent vials with confirmed defect causing prolonged prothrombin time (PT) readings. Affected lots expire 2018-2019. Stop using if you have these lots.
Diagnostica StagoOct 25, 2017
Diagnostica Stago, Inc. recall questions
How many recalls has Diagnostica Stago, Inc. had?
24 recalls from Diagnostica Stago, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Diagnostica Stago, Inc. recall?
Diagnostica Stago, Inc. recalls STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor, dated Jul 29, 2026. Every Diagnostica Stago, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Diagnostica Stago, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Diagnostica Stago, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.