# FDA recall Z-2549-2023

> **Landauer** · Class II · device recall initiated 2023-07-12.

## Product

Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; 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

- **Recall number:** Z-2549-2023
- **Recalling firm:** Landauer
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-07-12
- **Report date:** 2023-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glenwood, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2023

## Citation

> AI Analytics. FDA recall Z-2549-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2549-2023. Source: US FDA. Licensed CC0.

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