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Landauer recalls NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Recalled September 20, 2023 · FDA recall Z-2574-2023 · 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. · FDA Class II
Units
310 units
Sold at
Worldwide
Description
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.
Product
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Manufacturer(s)
Landauer
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →