FDA-Device2023-09-20Class II
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
Landauer
Hazard
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
Sold states
Worldwide
Affected count
632928 units
Manufactured in
2 Science Rd, Glenwood, IL, United States
Products
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2561-2023Don't want to check this manually?
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