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.
데이터 추가 비고
multi-analyte controls, all kinds (assayed) - Product Code jjy
원인
Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
조치
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
Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. || Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to assist 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.