Parsippany, NJ, United States
Diagnostica Stago, Inc. recalls
13 recalls recorded since 2018, most recently on 29 July 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls13
Ongoing (FDA)8
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 July 2026
- Reason
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Distribution
- US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3047-2026
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Ongoing Class II Medical devices
- Recall started
- 5 February 2026
- Reason
- After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1585-2026
- Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dime
Ongoing Class II Medical devices
- Recall started
- 4 February 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BIELORUSSIE, BRAZIL, BULGARIA, CANADA, CHILE, CHINA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1491-2026
- Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Com
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1084-2026
- Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type I
Ongoing Class II Medical devices
- Recall started
- 12 September 2025
- Reason
- A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
- Distribution
- Worldwide distribution- US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0205-2026
- Product: STA Liatest D-Di; REF: 00515;
Ongoing Class II Medical devices
- Recall started
- 21 July 2025
- Reason
- Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, I
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2474-2025, Z-2473-2025, Z-2475-2025, Z-2476-2025
- 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 Satellite analyzers, for the quantitative determination of the plasma levels of u
- STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
- 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 Satellite analyzers, for the quantitative determination of the plasma levels of
- STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen
Ongoing Class II Medical devices
- Recall started
- 21 May 2025
- Reason
- Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
- Distribution
- The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1993-2025
- STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Comp
Ongoing Class II Medical devices
- Recall started
- 22 March 2023
- Reason
- 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 analyzer (error 13).
- Distribution
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1576-2023, Z-1577-2023, Z-1575-2023
- STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
- STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
- STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Terminated Class II Medical devices
- Recall started
- 4 March 2020
- Terminated
- 10 November 2021
- Reason
- A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1699-2020
- STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer plat
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 12 January 2023
- Reason
- A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
- Distribution
- US: MA ME VT CT NJ NY PA DC MD VA NC SC GA FL AL TN MS KY OH IN MI IA WI MN SD ND MT IL MO KS LA AR OK TX CO AZ NV CA HI OR WA AK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0738-2020, Z-0737-2020
- STA SYSTEM CONROL N + P (ref. 00678)
- STA UNICALIBRATOR (ref. 00675)
Terminated Class II Medical devices
- Recall started
- 14 November 2018
- Terminated
- 8 June 2020
- Reason
- There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0611-2019, Z-0610-2019
- Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid
- Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid mo
Terminated Class II Medical devices
- Recall started
- 24 July 2018
- Terminated
- 18 May 2020
- Reason
- QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2994-2018, Z-2993-2018
- Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of t
- Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determ
Terminated Class II Medical devices
- Recall started
- 25 October 2017
- Terminated
- 12 May 2020
- Reason
- Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1069-2018, Z-1067-2018, Z-1068-2018, Z-1066-2018
- STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
- STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.