Z-2541-2023 Class II
FDA device recall Z-2541-2023 was initiated by Landauer on July 12, 2023 and is designated Class II. 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-confo… Affected quantity: 35681 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- July 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35681 units
Product Description
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; 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 Pattern
Worldwide
Code Information
UDI/DI 0860003399903, all batch numbers