Events

Recall of Device Recall Seradyn QMS Vancomycin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Seradyn, Inc..

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
    46150
  • Event Risk Class
    Class 2
  • Event Number
    Z-1102-2008
  • Event Initiated Date
    2007-12-20
  • Event Date Posted
    2008-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66885
  • 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
    Vancomycin Radioimmunoassay - Product Code LEH
  • Reason
    False negative test results due to interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
  • Action
    Consignees were notified of the problem via Urgent Medical Device Correction letter dated 12/20/07. The letter provided information on the issues concerning the recall. The firm will revise the package insert to address the potential occurrence of false negative bias. If inconsistencies with Vancomycin level exist, confirm with an alternative test method. For further information please contact 1-800-428-4072.

Device

Device Recall Seradyn QMS Vancomycin
  • Model / Serial
    All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.
  • Product Description
    Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
  • Manufacturer
    Seradyn, Inc.

Manufacturer

Seradyn, Inc.
  • Manufacturer Address
    Seradyn, Inc., 7998 Georgetown Rd, Indianapolis IN 46268-5631
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA