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.
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. as a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
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Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used.
For further information, contact Biosite, Inc. using the following information:
Biosite Incorporated, an Inverness Medical Company
9975 Summers Ridge Road
San Diego, CA 92121
Phone: 1-877-441-7440, option 2
Fax: 1-858-695-7100
Email: productadvisory@invmed.com
“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.