Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.
Alere Triage¿ TOX Drug Screen Control 1 || Product Generic Name: Quality Control Material || Description of the product: || Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment || of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control || procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures || described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results || obtained for the controls are to be compared with the assigned values given on the Expected Values Card, || accompanying the package insert, to determine if the procedure is within control limits. || Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of || human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. || 510(k)/IDE/PMA number: K060788 || Type of Packaging: 5 vials per level in a labeled kit box. || Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.
“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.