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    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·May 9, 2019

    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code FRO·March 28, 2007

    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).

    FDA Recall
    Terminated ·Biomerieux, Inc.·Product code GJS·February 4, 2003

    Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. (in vitro diagnostic use).

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·April 16, 2014

    Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,

    FDA Recall
    Terminated ·bioMerieux·Product code GJS·July 31, 2003

    Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

    FDA Recall
    Terminated ·Bard Access Systems·Product code FJS·May 21, 2011

    INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·December 5, 2014

    Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio 2 Monitor and INRatio 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

    AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt Business Center Drive, St. Louis, MO 63114, USA.

    FDA Recall
    Terminated ·Trinity Biotech USA·Product code GJS·October 27, 2004

    CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code GJS·February 28, 2007

    Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·December 5, 2014

    Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 25, 2017

    Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

    Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

    Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

    Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FJS·December 20, 2017

    Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·July 24, 2018

    CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code GJS·December 2, 2020

    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

    FDA Recall
    Open, Classified ·Fisher Diagnostics·Product code GJS·March 6, 2025

    Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code GJS·March 28, 2005