QC — Class II medical device recall Z-2558-2023
Completed recall by Landauer, reported 2023-09-20. LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +
| Recall number | Z-2558-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Landauer, Glenwood, IL, United States |
| Recall initiated | 2023-07-12 |
| Classified | 2023-09-12 |
| Reported by FDA | 2023-09-20 |
| Quantity | 2,240 units |
| UPC / GTIN / UDI-DI | 00860003399903 |
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2558-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.