Test, Qualitative And Quantitative Factor Deficiency
Hematology · 21 CFR 864.7290
Recent MDR events
23 adverse event reports on file
- VWF AGApr 24, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00009
- PROTEIN C REAGENTDec 10, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00054
- PROTEIN C REAGENTDec 4, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00053
- PROTEIN S ACMay 1, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00017
- INNOVANCE VON WILLEBRAND FACTOR ACTIVITYDec 29, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00057
- INNOVANCE VON WILLEBRAND FACTOR ACTIVITYDec 29, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00059
- INNOVANCE VON WILLEBRAND FACTOR ACTIVITYDec 29, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00058
- FACTOR VIII CHROMOGENIC ASSAYJun 6, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00041
- BC VON WILLEBRAND REAGENTMar 23, 2021MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2021-00029
- BC VON WILLEBRAND REAGENTMar 23, 2021MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2021-00030
Event type breakdown
Recalls
13 recall events for this product code
- Diagnostica Stago, Inc.Open, ClassifiedMar 3, 2026
Brand Name: STA Liatest Free Protein S
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.
Z-1491-2026 · View FDA record ↗ - Aniara Diagnostica LLCOpen, ClassifiedMar 6, 2023
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K depend
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
Z-1227-2023 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedFeb 1, 2016
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic su
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Z-0736-2016 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedDec 22, 2015
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitati
Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.
Z-0468-2016 · View FDA record ↗ - Sekisui Diagnostics LlcTerminatedDec 3, 2012
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma.
Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
Z-0463-2013 · View FDA record ↗ - Sekisui Diagnostics LlcTerminatedSep 20, 2012
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma.
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
Z-2431-2012 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedMay 10, 2012
Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit
Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.
Z-1519-2012 · View FDA record ↗ - American Diagnostica, Inc.TerminatedApr 21, 2010
REF 822 IMUBIND(R) Plasma PAI-1 ELISA
Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
Z-1426-2010 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedAug 9, 2007
STA Liatest Free Protein S
Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
Z-1072-2007 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedJul 3, 2007
STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.
Z-0853-2007 · View FDA record ↗
Registered firms
131 firms currently registered for this product code
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
Affinity Biologicals Inc.
ANCASTER Ontario, CA
Dsrv, Inc.
Mount Olive, NJ, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Helena Laboratories, Corp.
BEAUMONT, TX, US
Instrumentation Laboratory Co.
Bedford, MA, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Precision Biologic Inc.
Dartmouth Nova Scotia, CA
Rossix Ab
Molndal Vastra Gotaland, SE
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Corgenix, Inc.
BROOMFIELD, CO, US
510(k) clearances
190 clearances for this product code
- Precision Biologic, Inc.Aug 25, 2025
K251440 · CRYOcheck Chromogenic Factor VIII
- Instrumentation Laboratory CompanyDec 13, 2023
K230852 · HemosIL Chromogenic Factor IX
- Siemens Healthcare Diagnostics Products GmbHJun 2, 2023
K220728 · vWF Ag
- Precision Biologic, Inc.Dec 23, 2022
K214002 · CRYOcheck Chromogenic Factor IX
- Instrumentation Laboratory CODec 9, 2022
K223402 · HemosIL von Willebrand Factor Antigen
- Instrumentation Laboratory COAug 19, 2020
K200033 · HemosIL von Willebrand Factor Antigen
- Precision BiologicJul 17, 2020
K193204 · Cryocheck Chromogenic Factor VIII
- Precision Biologic, Inc.Mar 12, 2019
K183440 · CRYOcheck FVIII Inhibitor Kit