Events

Recall of Device Recall lmmunalysis EDDP Urine Control Set 1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alere San Diego Inc. DBA Immunalysis Corporation.

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
    80096
  • Event Risk Class
    Class 3
  • Event Number
    Z-2140-2018
  • Event Initiated Date
    2017-11-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164551
  • 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
    Enzyme immunoassay, methadone - Product Code DJR
  • Reason
    The high (125 ng/ml) control does not meet specification - it has been confirmed to produce values below 100 ng/ml when run on validated clinical chemistry analyzers, which is below the 100 ng/ml cutoff of the eddp specific urine enzyme immunoassay with which this control is utilized.
  • Action
    On November 28, 2017, the firm sent their customer notifications of the recall stating the following: CUSTOMER REQUIRED ACTION 1. If you have product in your possession: " Immediately discontinue use and/or sale of affected product lot and place in quarantine. " Complete the enclose Customer Verification Form, within 10 days, indicating the quantity of product you have discarded or will return to lmmunalysis. " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com " Upon receipt of your Customer Verification Form, we will initiate shipment of replacement product in the quantity indicated on the form and, if applicable, will contact you to arrange product return. " Return product as directed. 2. If you have no remaining product in your possession: " Complete the enclosed Customer Verification Form, within 10 days, indicating "We do not have any affected product - it has been consumed". " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com 3. Share this information with your staff and retain this notification as part of your records. Please complete this form and return within 10 days even if you do not have any remaining product. Send form to lmmunalysis at Fax 909-482-0850 or by e-mail to rtimbang@immunalysis.com For further questions, please call (207) 730-5738.

Device

Device Recall lmmunalysis EDDP Urine Control Set 1
  • Model / Serial
    Part Number: 3006-5, Lot Number: EK16135
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
  • Product Description
    lmmunalysis EDDP Urine Control Set 1 || The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.
  • Manufacturer
    Alere San Diego Inc. DBA Immunalysis Corporation

Manufacturer

Alere San Diego Inc. DBA Immunalysis Corporation
  • Manufacturer Address
    Alere San Diego Inc. DBA Immunalysis Corporation, 829 Towne Center Dr, Pomona CA 91767-5901
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA