Manufacturer

Diagnostica Stago, Inc.

26 recalls in our database name Diagnostica Stago, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 26
Critical: 0
Severe: 0
Most recent: 2026-03-25

Of the 26 recalls from Diagnostica Stago, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

HighFDA (Devices)·Z-1585-2026·2026-03-25
Stago D-dimer assay shows positive bias across entire analytical range
Diagnostica Stago is recalling the STA Liatest D-Di kit after investigations confirmed a positive bias in D-dimer measurements throughout the entire analytical range.
Product
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-dimer in venous plasma for use on STA-R, STA Compact and STA Sat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1491-2026·2026-03-11
Stago free protein S assay may underestimate normal range results
Diagnostica Stago is recalling four lots of the STA Liatest Free Protein S kit because of the potential for out-of-range results and underestimation of free protein S in normal patient plasmas.
Product
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 Compact¿ for the quantitative antigenic assay of free protein S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2026·2026-01-21
Lucky Ice mouthwash recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Lucky Ice Cool Mouthwash over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
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 II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0205-2026·2025-10-22
D-Dimer test reagents recalled over potential underestimation of measured levels
Diagnostica Stago is recalling 12,740 units of STA Liatest D-Di across two lots because of a potential risk of underestimating D-Dimer levels.
Product
Product: STA Liatest D-Di; REF: 00515;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2475-2025·2025-09-03
Anti-Xa test kits recalled over potential contamination by fibrinogen reagents
STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.
Product
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 unfractionated (UFH) and low molecular weight (LMWH) heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2474-2025·2025-09-03
Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination
STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.
Product
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 unfractionated (UFH) and low molecular weight (LMWH) heparins
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2476-2025·2025-09-03
Fibrinogen test kits recalled over potential cross-contamination in heparin assays
STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.
Product
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 levels in human citrated plasma by the clotting method of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2473-2025·2025-09-03
Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing
STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2025·2025-06-25
STA-Owren Koller Buffer Solution Recall Due to Clotting Time Concerns
Diagnostica Stago is recalling STA-Owren Koller buffer solution (Lot 270902) because it may produce shorter clotting times in certain tests, potentially leading to a 1% overestimate of clotting results.
Product
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 Compact, STA Satellite and ST art families.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1575-2023·2023-05-17
STA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results
Diagnostica Stago is recalling the STA R Max fully automatic clinical analyzer due to a firmware bug that causes intermittent shortened coagulation times and increased technical errors, potentially producing inaccurate blood clotting test results.
Product
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1577-2023·2023-05-17
STA Compact Max analyzer firmware bug causes inaccurate test results
A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.
Product
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1576-2023·2023-05-17
STA Compact Analyzer Firmware Bug Causes Inaccurate Test Results
Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.
Product
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1699-2020·2020-04-22
Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk
Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.
Product
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 platforms as follows: (A) STA-R Max, Product Codes: 58989, 5899
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0738-2020·2020-01-01
Diagnostica Stago Recalls STA System Control N + P Due to Positive Bias
Diagnostica Stago is recalling 5,437 units of STA System Control N + P because a positive bias was confirmed on specific calibrator levels.
Product
STA SYSTEM CONROL N + P (ref. 00678)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0737-2020·2020-01-01
Diagnostica Stago Recalls STA Unicalibrator Due to Positive Bias
Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.
Product
STA UNICALIBRATOR (ref. 00675)
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-0610-2019·2018-12-26
Diagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.
Product
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 molecules (1, 2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0611-2019·2018-12-26
Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.
Product
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 molecules (1, 2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2993-2018·2018-09-19
Diagnostica Stago Recalls STA N¿oplastine¿ CI Plus Reagents Due to Quality Control Failures
Diagnostica Stago is recalling 24,043 kits of STA N¿oplastine¿ CI Plus reagents because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.
Product
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 determination of the prothrombin time (PT) in plasma with STA-R¿,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2994-2018·2018-09-19
Diagnostica Stago Recalls STA N¿oplastine¿ CI Reagents Due to Quality Control Issues
Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.
Product
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 the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2018·2018-03-21
Diagnostica Stago Recalls Neoplastine Cl Plus Prothrombin Time Reagent Kits
Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.
Product
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1067-2018·2018-03-21
Diagnostica Stago Recalls Neoplastine Cl Plus Reagent Due to Homogeneity Defect
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.
Product
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1069-2018·2018-03-21
Diagnostica Stago Recalls STA Neoplastine Cl Plus Reagent Due to Homogeneity Defect
Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that may cause inaccurate prothrombin time test results.
Product
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1068-2018·2018-03-21
Diagnostica Stago Recalls STA Neoplastine Cl Reagent Due to Homogeneity Defect
Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.
Product
STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2650-2014·2014-09-24
Stago IVD Liquid Anti-Xa Recalled for Barcode Misreading
Diagnostica Stago is recalling 514 Liquid Anti-Xa kits due to customer complaints about barcode misreading on analyzers.
Product
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. 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 unfractionated (UFH) and low molecular weight (LMWH) heparins by meas
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0951-2013·2013-03-20
Diagnostica Stago Recalls LIATEST VWF:Ag Coagulation Assay Kits
Diagnostica Stago is recalling LIATEST VWF:Ag kits because measurement errors may lead to lowered percentage results.
Product
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO
Category
Medical Device
Distribution
0 states