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    VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·February 6, 2012

    VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·November 14, 2013

    VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·February 6, 2012

    VerifyNow P2Y12 Assay Device Kit, Part Number 85054

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·September 5, 2006

    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·February 13, 2014

    VerifyNow Asprin Assay Kit Part No. 85034

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·May 10, 2004

    Accumetrics part number 29001 VerifyNow Instrument, printe power supply

    FDA Recall
    Terminated ·Accumetrics Inc·Product code JOZ·September 13, 2005

    The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.

    FDA Recall
    Terminated ·Accriva Diagnostics, Inc.·Product code JOZ·March 30, 2022

    CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution

    FDA Enforcement
    Class II ·Terminated·Custom Medical Specialties, Inc.·September 19, 2012

    CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution

    FDA Recall
    Terminated ·Custom Medical Specialties, Inc.·Product code LRP·September 30, 2011

    Amerigel Wound Dressing 1 oz. tube

    FDA Recall
    Terminated ·Kova Laboratories, Inc.·Product code MGQ·March 21, 2014

    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

    FDA Recall
    Terminated ·Medegen Medical Products, LLC·Product code KCP·April 30, 2003

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code LPN·September 19, 2016

    Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.

    FDA Recall
    Terminated ·Cardinal Health·Product code KMJ·February 28, 2011

    E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL HAND SWITCHING (2) ABSORBENT TOWELS 15" X 20" L/F (1) DRAPE SHEET 41 " X 58" SMS L/F (1) EAR/ULCER SYRINGE 2oz LIF (2) MEDICINE CUP 2oz (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) *Pr. SURGICAL GLOVES #7% POWDER (1) *Pr. SURGICAL GLOVES #7 POWDER (9) LABEL FOR SKIN MARKER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

    FDA Enforcement
    Class II ·Terminated·Amerx Health Care Corp.·July 27, 2016

    Amerigel Wound Dressing 1 oz. tube

    FDA Enforcement
    Class II ·Terminated·Kova Laboratories, Inc.·July 16, 2014

    Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes)

    FDA Recall
    Terminated ·BioMed Laboratories·Product code GDS·August 16, 2010

    Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code KMJ·May 20, 2016

    Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)

    FDA Recall
    Terminated ·BioMed Laboratories·Product code GDS·August 16, 2010