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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

Xprecia Stride™ Coagulation Analyzer — Siemens Healthcare Diagnostics Inc.George King Heparin Control Plasma — GEORGE KING BIO-MEDICAL, INCHemosIL D-Dimer HS 500 Controls — INSTRUMENTATION LABORATORY COMPANYHemosIL Normal Control ASSAYED — INSTRUMENTATION LABORATORY COMPANYGeorge King Coumadin® Plasma — GEORGE KING BIO-MEDICAL, INCi-STAT — ABBOTT POINT OF CARE INC.George King Pooled Normal Plasma — GEORGE KING BIO-MEDICAL, INCVisuCon-F Frozen Abnormal Control Plasma — Affinity Biologicals IncLyphochek — BIO-RAD LABORATORIES, INC.Control Plasma LMW Heparin — INSTRUMENTATION LABORATORY COMPANYNA — MEDTRONIC, INC.Heparin/PF4 Antibody Serum Panel — AKERS BIOSCIENCES, INC.GEM Check Coag Control-Normal for Citrate PT — INSTRUMENTATION LABORATORY COMPANYControl Plasma N — Siemens Healthcare Diagnostics Products GmbHVisuCon-L Coag Screen N Plasma — Affinity Biologicals IncThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsSTA® - Liatest® Control N + P — DIAGNOSTICA STAGOdirectCHECK ACT+ Whole Blood Control, Level 2 — ACCRIVA DIAGNOSTICS HOLDINGS, INC.N/A — MEDTRONIC, INC.STA® - Control LA 1 + 2 — DIAGNOSTICA STAGOLiquichek — BIO-RAD LABORATORIES, INC.PlasmaRef ARL-2 — R 2 DIAGNOSTICS, INC.HemosIL Apixaban Controls — INSTRUMENTATION LABORATORY COMPANYGEM Check Coag Control-Abnormal for Citrate PT — INSTRUMENTATION LABORATORY COMPANY

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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