Radiation Monitoring Dosimeter Potential Accuracy Error: Worldwide Landauer nanoDot Recall
Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters worldwide due to a potential non-conformance that could cause some units to measure radiation exposure outside the specified +/-5.5% accuracy range.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard is a potential measurement inaccuracy in radiation monitoring equipment, which poses a risk of harm through improper radiation protection decisions but no actual harm has been reported. Per the rubric, this qualifies as High: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters (model numbers 03062-1MO, 03062-3MO, 03062-OTO, and 03062-SMO) with UDI/DI 0860003399903 in all batch numbers. These are personal radiation dosimeters used with microSTAR readers to monitor occupational radiation exposure.
A potential non-conformance was identified in the Optical Stimulated Luminescence (OSL) material component of the dosimeters. This defect could cause some devices to measure radiation exposure outside the specified accuracy range of ±5.5%, resulting in inaccurate exposure readings that do not meet product specifications.
Individuals and facilities using these dosimeters should immediately contact Landauer to report their use and receive replacement or corrective instructions. Inaccurate radiation dosimetry could compromise radiation protection decisions and worker safety monitoring. The recall affects all batch numbers of the affected models distributed worldwide.
The recalled product
- Product
- nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- radiation-monitoring-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 0860003399903
- all batch numbers
Distribution
Distribution scope not specified by the agency.
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