Events

Recall of Device Recall ADVIA 1650 Chemistry System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bayer Healthcare, LLC (Diagnostics Division).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35880
  • Event Risk Class
    Class 2
  • Event Number
    Z-1448-06
  • Event Initiated Date
    2006-02-17
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47080
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated Clinical Chemistry Analyzer - Product Code JGS
  • Reason
    Low qc recovery observed on carbamazepine (carb) results immediately following a gentamicin (gent) assay or a digoxin (dig) assay. when gent or dig precedes carb, the carb test result is artificially low (as much as -25%). phny was determined to also exhibit a similar carryover effect on carb. all others were found not to produce the same reagent probe-based carryover effect.
  • Action
    Bayer HealthCare LLC issued a Support Bulletin to all affected Bayer HealthCare LLC Branches on/about 2/17/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Customer Bulletins were also issued to the Branches both in the United States and elsewhere for communication with the affected customers.

Device

Device Recall ADVIA 1650 Chemistry System
  • Model / Serial
    Part No. 073-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA and Puerto Rico.
  • Product Description
    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)
  • Manufacturer Address
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
  • Source
    USFDA