FreeStyle Flash and FreeStyle Blood Glucose Monitoring System
Model / Serial
FreeStyle Flash Blood Glucose Meter
FreeStyle Blood Glucose Meter
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FDA update code:
Part number CAT11001-0; all serial numbers
Catalog Number 17002 NDC 99073-0170-02. All serial numbers
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MHRA update code :
- FreeStyle Mini blood glucose meter
- FreeStyle Navigator (Version 1.0 and 1.5)
“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.