Events

Recall of Device Recall IDS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by IDS (Immunodiagnostic Systems Ltd.).

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
    63840
  • Event Risk Class
    Class 2
  • Event Number
    Z-0697-2013
  • Event Initiated Date
    2012-11-07
  • Event Date Posted
    2013-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114873
  • 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
    System, test, vitamin d - Product Code MRG
  • Reason
    Immunodiagnostic systems is recalling the 25-hydroxy vitamin d eia, ac-57f1 because the qc report was found to have an erroneous calibrator value assigned. the value of 24.4 ng/ml for calibrator 4 was stated on the qc report, however the correct value should have read 28.4 ng/ml.
  • Action
    IDS sent a recall notification letter on November 7, 2012 to all customers that received the the 25-Hydroxy Vitamin D EIA (AC-57F1). The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete the attached Recall and Acknowledgement Form and fax back to Immunodiagnostic Systems Inc. Customers with questions are instructed to contact their local IDS office.

Device

Device Recall IDS
  • Model / Serial
    Lot # 17628
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. || Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
  • Manufacturer
    IDS (Immunodiagnostic Systems Ltd.)

Manufacturer

IDS (Immunodiagnostic Systems Ltd.)
  • Manufacturer Address
    IDS (Immunodiagnostic Systems Ltd.), Usworth Hall, Washington United Kingdom
  • Source
    USFDA