PlainRecalls
FDA Devices Moderate Class II Completed

Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers

Reported: September 20, 2023 Initiated: July 12, 2023 #Z-2575-2023

Product Description

Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers

Reason for Recall

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.

Details

Recalling Firm
Landauer
Distribution
Worldwide
Location
Glenwood, IL

Frequently Asked Questions

What product was recalled?
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers. Recalled by Landauer.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 20, 2023. Severity: Moderate. Recall number: Z-2575-2023.