Events

Recall of Triage Cardiac Panel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosite 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
    51925
  • Event Risk Class
    Class 1
  • Event Number
    Z-1391-2009
  • Event Initiated Date
    2009-04-27
  • Event Date Posted
    2009-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81652
  • 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
    Cardiac Markers Test - Product Code MMI
  • Reason
    The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin i and myoglobin, possibly resulting in missed or incorrect diagnosis.
  • Action
    The recall was initiated with "Urgent Medical Device Recall" notices, dated 4/28/2009, with attached "Customer/Distributor Verification Form" being sent to the affected customers via fax, e-mail or direct mail on 04/28/2009. Customers were informed of the reason for the recall and instructed to immediately discontinue all use of the listed products and discard all affected product in accordance with your their regulations. The customers were give two options; "Option 1: Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of kits discarded from your inventory and product replacement will be sent to you. Option 2: Contact inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt. A representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you." Customers were also provided telephone, fax and e-mail contact information for Biosite should they have any questions about the information contained in the recall notification.

Device

Triage Cardiac Panel
  • Model / Serial
    Lot Number W44467B
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. || Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, creatine kinase MB fraction (CK-MB), and troponin I in EDTA whole blood and plasma specimens. These three cardiac biomarkers are used as an aid in the diagnosis of myocardial infarction (injury).
  • Manufacturer
    Biosite Inc

Manufacturer

Biosite Inc
  • Manufacturer Address
    Biosite 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