FDA recall Z-2572-2023

Landauer · Class II · device

Product

Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; 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.

Distribution

Worldwide

Key facts

Status: Completed
Initiation date: 2023-07-12
Report date: 2023-09-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Glenwood, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2572-2023