Z-2542-2023 Class II
FDA device recall Z-2542-2023 was initiated by Landauer on Jul 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… Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 20, 2023
- Initiation Date
- Jul 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2542-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026