Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNN radiation dosimeters because some units may have measurement accuracy outside their specified +/-5.5% range. Worldwide users should contact the manufacturer to verify device performance.
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 involving a radiation monitoring device where measurement inaccuracy has not yet resulted in reported illnesses or injuries. This qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Landauer is recalling nanoDot D2DNN radiation dosimeters used with microSTAR readers. Approximately 35,681 units distributed worldwide are affected (model numbers: 03053-1MO, 03053-1WK, 03053-3MO, 03053-OTO, 03053-SMO).
Some nanoDots may have measurement accuracy outside the specified +/-5.5% range due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that emits fluorescence proportional to radiation exposure.
Workers and facilities using affected dosimeters should contact Landauer to verify device accuracy and obtain calibration verification or replacement units. A radiation dosimeter that reads inaccurately could fail to properly detect and measure occupational radiation exposure.
The recalled product
- Product
- nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- accuracy-drift
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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