microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100… — recall Z-1349-2024
U.S. FDA — Device Enforcement · United States · 2024-02-08 · Class II
As described by U.S. FDA — Device Enforcement: microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
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Completed — the recalling firm has completed its actions
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Brazil, Canada, China, France, India, Japan, Jordan, Malaysia, Mexico, Pakistan, Peru, Philippines, Rep of Korea, Singapore, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, Viet Nam.
Reported risk: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
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