Events

Recall of Cholestech LDX Calibration Verification

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosite Inc Dba Innovacon 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
    56985
  • Event Risk Class
    Class 2
  • Event Number
    Z-0443-2011
  • Event Initiated Date
    2010-10-06
  • Event Date Posted
    2010-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95114
  • 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
    Multi-Analyte Controls - Product Code JJY
  • Reason
    The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
  • Action
    All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010. Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. Consignees with questions about the information contained in the notification were instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877 441 7440 FAX: 858 805 8457 E-mail: Response.ts@alere.com

Device

Cholestech LDX Calibration Verification
  • Model / Serial
    Lot # 0146
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
  • Product Description
    Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. || To be used for verifying the reportable range of tests on the Cholestech LDX System.
  • Manufacturer
    Biosite Inc Dba Innovacon Inc.

Manufacturer

Biosite Inc Dba Innovacon Inc.
  • Manufacturer Address
    Biosite Inc Dba Innovacon Inc., 9975 Summers Ridge Rd, San Diego CA 92121
  • 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