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.
Alere san diego received a rise in customer complaints regarding false positive barbiturates (bar) results on the triage drugs of abuse panel plus tca.
조치
Alere sent a "PRODUCT NOTIFICATION" letter dated January 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return to the firm. Contact Technical Services at 1-877-308-8287.
Part 90008: lot 259403 exp 02/03/13, lot 267081 exp 05/08/13 Part 92000: lots 254662, 255830, 257527, 262143 with exp 01/06/13; lots 259628, 259954 with exp 02/03/13 Part 92002: lot 234295 exp 02/03/13
Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia.
제품 설명
Product Brand Names: Triage¿ Drugs of Abuse Panel 8 Test Kit (K924476), Triage¿ Drugs of Abuse || Panel Plus TCA (K973784), & Triage¿ Drugs of Abuse Panel Plus PPX (K014247) || Model Number: 90008, 92002, & 92000 || Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices || in a labeled kit box. || The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, || ASCENDTM MULTIMMUNOASSAY¿ (AMIATM). Each AMIATM assay is a competitive binding immunoassay || in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for || antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the || Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a || zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the || unbound conjugate and clear the background. Test results are visually read. || The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine.
“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.