Events

Recall of IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Immunodiagnostics Systems 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
    49393
  • Event Risk Class
    Class 3
  • Event Number
    Z-0173-2009
  • Event Initiated Date
    2008-08-02
  • Event Date Posted
    2008-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73245
  • 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
    Vitamin D test system - Product Code MRG
  • Reason
    A small number of customers have experienced low absorbance values when using kits from this batch.
  • Action
    All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail. Customers were instructed to sign a confirming document for having received the notification letter and return via fax. Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008. Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.

Device

IDS 25Hydroxy Vitamin D EIA Enzymeimmunoassay
  • Model / Serial
    Lot Code #60897
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma
  • Manufacturer
    Immunodiagnostics Systems Inc

Manufacturer

Immunodiagnostics Systems Inc
  • Manufacturer Address
    Immunodiagnostics Systems Inc, 17029 E Enterprise Dr Ste 1, Fountain Hills AZ 85268
  • Source
    USFDA