Radiation dosimeter recalled for potential measurement accuracy deviations
Landauer recalled nanoDot D2DNS radiation dosimeters worldwide due to potential inaccuracy in Optical Stimulated Luminescence material. Some units may read 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: FDA Class II medical device with no reported injuries. However, radiation dosimeters are risk-of-harm products; measurement inaccuracy could compromise radiation safety decisions. This qualifies as risk-of-harm product where injury has not yet been reported per the rubric.
Plain-English summary
Landauer is recalling its QC (Cs-137) screened nanoDot D2DNS radiation dosimeter (Model Number 03067-OTO) worldwide. The dosimeter is a radiation monitoring device used with microSTAR readers to measure occupational and medical radiation exposure. All batch numbers are included in the recall.
Landauer received reports indicating some nanoDots may measure outside the specified accuracy range of ±5.5%. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which emits fluorescence proportional to radiation exposure and is used to calculate dose readings. Inaccurate measurements could affect decisions about radiation safety and exposure management.
No illnesses or injuries have been reported in connection with this recall. Users of affected dosimeters should contact Landauer for guidance on verification or replacement.
The recalled product
- Product
- QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- material-defect
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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