BEUDAMED
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    RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CHL·April 4, 2006

    RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CHL·April 4, 2006

    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code GKL·March 16, 2006

    ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JJE·August 4, 2006

    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code JGS·February 17, 2006

    Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code JGS·February 17, 2006

    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code JGS·February 17, 2006

    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

    FDA Enforcement
    Class II ·Terminated·Bayer Healthcare Llc·November 13, 2013

    ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

    FDA Recall
    Terminated ·Bayer Healthcare Llc·Product code LCP·August 26, 2013

    Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011

    ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JJE·November 9, 2006

    Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.

    FDA Recall
    Terminated ·Bayer Healthcare LLC·Product code LFR·June 6, 2007

    Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC·Product code JJX·June 22, 2015