medical Class II Updated 2023-09-20

Landauer recalls Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 0306

Recalled Product

Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: UDI/DI 0860003399903, all batch numbers
View official government recall

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