Radiation Dosimeter Recall: nanoDot D2DNN Accuracy Outside Specifications
Landauer is recalling nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.
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 with no reported illnesses or injuries. The hazard is theoretical—potential measurement inaccuracy—without any documented harm. Per the recall rubric, this meets the threshold for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Landauer is recalling the nanoDot D2DNN radiation dosimeter (Model Numbers 18105-000 and 18105-KIT) worldwide. This device measures radiation exposure in conjunction with Landauer's microSTAR readers. Approximately 36,805 units are affected.
Some nanoDots may provide inaccurate measurements—specifically, accuracy may fall outside the specified range of plus or minus 5.5 percent. The problem stems from a potential defect in the Optical Stimulated Luminescence material inside the device. This material is responsible for emitting fluorescence when exposed to radiation, which the dosimeter then reads and uses to calculate exposure levels.
No illnesses or injuries related to this issue have been reported. Affected units are identified by the UDI/DI code 0860003399903, which covers all batch numbers.
The recalled product
- Product
- nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- radiation-exposure
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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