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    Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·March 7, 2019

    Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

    FDA Recall
    Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019

    LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·January 24, 2020

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany·Product code LXH·September 11, 2024

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

    FDA Recall
    Terminated ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany·Product code HWT·July 16, 2013

    Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

    FDA Recall
    Open, Classified ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019

    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code LOL·March 9, 2020

    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code LOL·November 7, 2019

    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JKC·December 14, 2017

    Alinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Recall
    Terminated ·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·June 10, 2019