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    1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HBG·December 21, 2011

    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HRY·November 25, 2008

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Recall
    Terminated ·BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom·Product code GHH·June 1, 2016

    Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LOM·August 27, 2004

    Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LOM·December 15, 2005

    AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LOM·April 23, 2007

    DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LLM·March 14, 2007

    Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl-Zeiss-Promenade 10 Jena Germany·Product code HLM·August 6, 2020

    VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom·Product code LOM·February 1, 2007

    Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LOM·May 14, 2007

    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LOM·August 20, 2013

    IMMULITE 2000/IMMULITE 2000 XPi Anti HBc

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018

    AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LOM·April 23, 2007

    ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LOM·May 14, 2007

    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code LOM·December 18, 2012

    VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LOM·October 25, 2013

    ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LOM·May 14, 2007

    Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LOM·August 11, 2008

    ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LOM·August 19, 2010

    Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LOM·September 15, 2014