The kit lots have the following lot numbers: 052534, 052592, 052296, 052536 (expiration date of 2007-02-09);and 052106 (exp. date 2006-08-09), and with storage requirements at between 2-8¿C. The nonconforming kit compoinent is the Negative Control (labeled ''CONTROL --''). There are two Negative Control lots affected. Both have the same expiration date of 2007-02-21 with one lot number being Ch.-B.502186301 (for kit lots 052534 and 052106) and the other lot number being Ch.-B.502186302 (for kit lots 052592, 052296 and 052536).
Worldwide distribution ---- USA including states of MN, CA, NJ, WA, IL, CO,and NY and countries of Canada, Spain, Bulgaria, UK, Lebanon, Russia, Columbia, South Africa, Italy, Sweden, Germany, Norway, Venezuela, Japan, Tunisia, Cyprus, The Netherlands, Greece, Israel, and India.
Description du dispositif
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
“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.