Events

Recall of Device Recall Triage Total Controls Calibration Verification 5

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
    54276
  • Event Risk Class
    Class 2
  • Event Number
    Z-1790-2010
  • Event Initiated Date
    2009-02-06
  • Event Date Posted
    2010-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88102
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    multi-analyte controls, all kinds (assayed) - Product Code jjy
  • Reason
    Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
  • Action
    The firm, Biosite Incorporated, sent an "URGENT MEDICAL DEVICE RECALL" dated February 6, 2009, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to immediately discontinue all use and/or sale of the listed products, discard all affected product in accordance with their local regulations, complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice, to indicate the number of kits discarded from their inventory and the product replacement will be sent to them. Contact Inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt and a representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you. Should you have any questions about the information contained in this notification, please contact (877) 441-7440 or email: Recalls@biosite.com

Device

Device Recall Triage Total Controls Calibration Verification 5
  • Model / Serial
    Model 88755 Lots 194444 & 194450
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. || Intended use: Materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
  • 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