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Plasma, Coagulation Control

FDA product code GGN · Class 2 · Hematology

251
Registered devices
148
Adverse events
16
Recalls
99
510(k) clearances

Devices with this code

directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC.directCHECK ACT-LR Whole Blood Controls, Level 1 — ACCRIVA DIAGNOSTICS HOLDINGS, INC.BIOPHEN Heparin Calibrator — HYPHEN BIOMEDVisuCon-F Frozen Coag Screen ABN — Affinity Biologicals IncINNOVANCE Heparin UF Control 1 — Siemens Healthcare Diagnostics Products GmbHGeorge King SysCOR Kit — GEORGE KING BIO-MEDICAL, INCHemosIL Abnormal Control 3 — INSTRUMENTATION LABORATORY COMPANYVisuCon-L Coag Screen ABN2 Plasma — Affinity Biologicals IncGeorge King Pooled Normal Plasma — GEORGE KING BIO-MEDICAL, INCINNOVANCE Heparin LMW Control 1 — Siemens Healthcare Diagnostics Products GmbHHemosIL Factor V Deficient Plasma (10 X 1 mL) — INSTRUMENTATION LABORATORY COMPANYDade Ci-Trol Coagulation Control Level 3 — Siemens Healthcare Diagnostics Products GmbHSTA® - Control LA 1 + 2 — DIAGNOSTICA STAGOCRYOcheck™ Abnormal 1 Reference Control — Precision Biologic IncCRYOcheck™ Abnormal 2 Control — Precision Biologic IncGeorge King Pooled Normal Plasma — GEORGE KING BIO-MEDICAL, INCGeorge King Single Normal Donor Plasma — GEORGE KING BIO-MEDICAL, INCGeorge King SysCOR-40 Control Kit — GEORGE KING BIO-MEDICAL, INCGeorge King Pooled Normal Plasma — GEORGE KING BIO-MEDICAL, INCIDG/Sanzay — IDG/SANZAY CorporationHemosIL Apixaban Controls — INSTRUMENTATION LABORATORY COMPANYVisuCon-F Frozen Coag Screen N — Affinity Biologicals IncGEM Check Coag Control-Normal for APTT — INSTRUMENTATION LABORATORY COMPANYROTEM® — Tem Innovations GmbH

Recent recalls

DateFirmReason
2026-07-01Aniara Diagnostica LLCStability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of me
2026-04-30Accriva Diagnostics, Inc.Assayed Whole blood control contains labeling with incorrect performance range.
2022-06-28Aniara Diagnostica LLCIncorrect product labeling was included in the package.
2019-11-18Diagnostica Stago, Inc.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 St
2019-03-19Aniara Diagnostica LLCThe manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19Aniara Diagnostica LLCThe manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19Aniara Diagnostica LLCThe manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2016-02-18TEM Systems IncCustomer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by
2013-11-15Instrumentation Laboratory Co.HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
2013-11-15Instrumentation Laboratory Co.HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

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