Landauer nanoDot radiation dosimeters recalled for measurement accuracy defect
Landauer recalled 5,760 nanoDot D2DNN radiation dosimeter units worldwide due to potential inaccuracy in radiation measurement. Some units may read outside the specified +/-5.5% accuracy range due to a defect in the optical stimulated luminescence material.
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: FDA Class II recall of medical device with potential accuracy defect in radiation measurement function. No injuries or illnesses have been reported; the hazard is theoretical based on detected manufacturing non-conformance. Qualifies as risk-of-harm product where injury has not yet been reported.
Plain-English summary
Landauer recalled 5,760 nanoDot D2DNN radiation monitoring dosimeters (Model Numbers 03051-1MO, 03051-3MO, 03051-OTO, and 03051-SMO) distributed worldwide. These devices are used with microSTAR readers to monitor occupational radiation exposure.
Investigation revealed that some units may read outside the specified +/-5.5% accuracy range. The root cause was identified as a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which measures radiation exposure and emits proportional fluorescence used in dosimeter readings.
The recall covers all batch numbers with UDI/DI 0860003399903. Users of affected dosimeters should contact Landauer for replacement or remediation to ensure accurate workplace radiation monitoring.
The recalled product
- Product
- nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- equipment-malfunction
- dosimetry-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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