FDA Device recall Z-2554-2023
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000
- FDA Device
- Class II
- completed
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000 by Landauer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2554-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-07-12 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Landauer |
| Distribution | n/a |
Product
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Reason
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.
Identifiers
| code_info | UDI/DI 0860003399903, all batch numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2554-2023%22
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