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Test, Qualitative And Quantitative Factor Deficiency

FDA product code GGP · Class 2 · Hematology

119
Registered devices
23
Adverse events
14
Recalls
190
510(k) clearances

Devices with this code

ACTICLOT PROTEIN S — Biomedica ADI Inc.Chrono-log — CHRONO-LOG CORPLyophilized Platelets — TCOAG IRELAND LIMITEDvW Abnormal Control Plasma — Bio/Data CorporationHemosIL von Willebrand Factor Antigen — INSTRUMENTATION LABORATORY COMPANYFactor IX Deficient Substrate Plasma — HELENA LABORATORIES CORPORATIONProtein S Ac — Siemens Healthcare Diagnostics Products GmbHTris-Tricine Buffer — HELENA LABORATORIES CORPORATIONProtein S ELISA Kit — HELENA LABORATORIES CORPORATIONLiatest® Protein S — DIAGNOSTICA STAGOvW Normal Control Plasma — Bio/Data CorporationSTA® - Staclot® Protein S — DIAGNOSTICA STAGOFactor VIII Deficient Substrate Plasma — HELENA LABORATORIES CORPORATIONProtein S Antigen Rocket Kit — HELENA LABORATORIES CORPORATIONHuman Protein C ‘NL’ NANORIDTM Radial Immunodiffusion Kit — THE BINDING SITE GROUP LIMITEDBerichrom® Protein C — Siemens Healthcare Diagnostics Products GmbHBIOPHEN Protein C 2.5 — HYPHEN BIOMEDCRYOcheck™ FVIII Inhibitor Kit — Precision Biologic IncProtein C Antigen Rocket Kit — HELENA LABORATORIES CORPORATIONTriniLIZE™ PAI-1 Antigen — TCOAG IRELAND LIMITEDFactor VIII Chromogenic Assay — Siemens Healthcare Diagnostics Products GmbHINNOVANCE Free PS Ag — Siemens Healthcare Diagnostics Products GmbHSTA® - Liatest® Free Protein S 6 — DIAGNOSTICA STAGORistocetin Cofactor Assay Kit — HELENA LABORATORIES CORPORATION

Recent recalls

DateFirmReason
2026-07-29Diagnostica Stago, Inc.A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
2026-02-04Diagnostica Stago, Inc.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.
2023-02-01Aniara Diagnostica LLCNew warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which ch
2020-03-04Diagnostica Stago, Inc.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 facto
2017-04-04Helena Laboratories, Inc.Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Sub
2015-12-18Instrumentation Laboratory Co.This Lot is not meeting labeled on-board instrument stability claims of 5 days.
2015-11-19Siemens Healthcare Diagnostics, Inc.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, C
2012-10-24Sekisui Diagnostics LlcSpectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more fre
2012-08-28Sekisui Diagnostics LlcSPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring
2012-04-11Instrumentation Laboratory Co.Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.

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