Device Recall Cardiac Marker Control Level 1, Cardiac Marker Control Level 2, & Cardiac Marker Control Level 3
모델명 / 제조번호(시리얼번호)
Cardiac Marker Control Level 1 - Lot number M102081; Cardiac Marker Control Level 2 - Lot number M102082; and Cardiac Marker Control Level 3 - Lot number M102083.
Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. || Used to verify the integrity of newly received i-STAT cTnI cartridges.
“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.