BEUDAMED
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    STA SYSTEM CONROL N + P (ref. 00678)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·November 18, 2019

    HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013

    BIOPHEN UFH Control C1, REF 224101

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

    GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.

    FDA Recall
    Terminated ·International Technidyne Corporation·Product code GGN·July 8, 2010

    BIOPHEN UFH Control Plasma

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·June 28, 2022

    International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.

    FDA Recall
    Terminated ·International Technidyne Corp.·Product code GGN·June 25, 2010

    HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013

    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

    FDA Recall
    Terminated ·TEM Systems Inc·Product code GGN·February 18, 2016

    BIOPHEN UFH Control C2, REF 223901

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

    BIOPHEN LMWH Control C4, REF 224201

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

    STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase time. Do not use the STA -System Control N+P kit on STA Satellite for the control of the APTT performed with the STA-rTT kit.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·August 23, 2011

    HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013

    directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.

    FDA Recall
    Terminated ·International Technidyne Corporation·Product code GGN·April 15, 2010

    GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.

    FDA Recall
    Terminated ·International Technidyne Corporation·Product code GGN·July 8, 2010

    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code KTT·February 22, 2006

    Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel

    FDA Recall
    Terminated ·Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel·Product code FMF·August 6, 2004

    EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·October 31, 2012

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Enforcement
    Class II ·Terminated·Organon Teknika Inc·March 6, 2019

    GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KPA·May 29, 2008

    Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.

    FDA Recall
    Terminated ·McKesson Provider Technologies Medical Imaging Group·Product code DQK·January 27, 2010