BEUDAMED
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    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 20, 2021

    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

    FDA Recall
    Terminated ·Hero Health·Product code NXB·July 2, 2021

    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 23, 2020

    Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.

    FDA Recall
    Terminated ·Hypoguard USA, Inc.·Product code CGA·November 26, 2003

    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·November 17, 2003

    ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter model no. 777.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 2138930.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with meter model no. 3288650.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·April 22, 2009

    GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·August 20, 2010

    Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·February 12, 2010

    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system

    FDA Recall
    Terminated ·Epocal Inc·Product code CGA·June 28, 2011

    OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·January 13, 2003

    Clinical Chemistry Phosphorus assay

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CEO·May 4, 2010

    Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CEO·January 30, 2007

    AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404, and/or Replacement GTS with Accu-Chek Advantage blood gulcose meter, Cat. no. 404R, and/or Replacement Base Unit with Advantage Module, Cat. no. 3426050. Ref. nos. 030002490001 and 03136833001 both have meters with model no. 777.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·February 21, 2008

    Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips

    FDA Recall
    Terminated ·Hypoguard USA, Inc.·Product code CGA·November 26, 2003

    i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code CGA·September 20, 2010