BEUDAMED
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    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

    FDA Recall
    Open, Classified ·Stryker Communications·Product code FQO·January 29, 2021

    Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFR·June 29, 2017

    Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017

    Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CIG·June 29, 2017

    McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS

    FDA Recall
    Terminated ·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021

    McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS

    FDA Recall
    Terminated ·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021

    Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KLI·June 29, 2017

    Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·June 29, 2017

    Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NRP·June 29, 2017

    Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFR·June 29, 2017

    McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS

    FDA Recall
    Terminated ·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021

    Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CIT·June 29, 2017

    Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIF·June 29, 2017

    Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CKA·June 29, 2017

    McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS

    FDA Recall
    Terminated ·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021

    Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CIT·June 29, 2017

    Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017

    Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CKA·June 29, 2017

    Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGS·June 29, 2017

    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DKJ·June 29, 2017