Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift
Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.
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 recall of a risk-of-harm medical device with no reported injuries or illnesses. The hazard is potential accuracy drift that could affect radiation dose measurements. Since no hospitalizations have been reported and the harm is theoretical rather than confirmed, this meets the rubric criteria for Score 3 (High).
Plain-English summary
Landauer is recalling nanoDot radiation monitoring dosimeter kits (Model 03500-000, containing nanoDot A, B, and C units) that are used with microSTAR readers. The recall affects approximately 16,760 units distributed worldwide.
The recalled units may potentially measure radiation exposure outside the specified accuracy range of +/-5.5%. Investigation identified a non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeter, which emits fluorescence proportional to radiation exposure and is used to calculate dose measurements.
The recalled product
- Product
- nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-error
- calibration-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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