BEUDAMED
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    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·June 14, 2017

    Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041

    FDA Enforcement
    Class II ·Terminated·Ra Medical Systems, Inc.·May 20, 2020

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Zhejiang Kindly Medical Devices Co., Ltd.·November 17, 2021

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

    FDA Enforcement
    Class II ·Terminated·Zhejiang Kindly Medical Devices Co., Ltd.·November 17, 2021

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

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

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    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