Diagnostica Stago recalls
8 official recalls and safety alerts involving Diagnostica Stago since 2023-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Diagnostica Stago or the relevant agency.
- 2026-09-09
USDiagnostica Stago, Inc. recalls STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
FDA · DeviceDiagnostica Stago, Inc.US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA,…Official notice →- 2026-03-25
- US
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The…
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Singapore,…Official notice → - 2026-03-11
- US
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description:…
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice → - 2026-01-21
- US
Diagnostica Stago, Inc. recalls Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of…
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI,…Official notice → - 2025-10-22
- US
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution- US Nationwide and the country of Canada.Official notice → - 2025-09-03
- US
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 Compact and STA…
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL,…Official notice → - 2025-06-25
- US
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and…
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
FDA · DeviceDiagnostica Stago, Inc.The affected lot was distributed to customers in various US states in October…Official notice → - 2023-05-17
- US
Diagnostica Stago, Inc. recalls STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the…
FDA · DeviceDiagnostica Stago, Inc.US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.Official notice →