127 results
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10ms
·
Sources: EU EUDAMED, US FDA
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
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
COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKL·April 18, 2007
Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
FDA Recall
Terminated
·Beckman Coulter Inc·December 10, 2002