Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.
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 recall of a radiation dosimeter with potential accuracy non-conformance. The source does not report illnesses or injuries. This constitutes a risk-of-harm product where injury has not yet been reported, per the Score 3 criterion.
Plain-English summary
Landauer is recalling nanoDot A radiation monitoring dosimeters, Model Number 03501-000, used with microSTAR readers. Approximately 16,820 units with UDI/DI 0860003399903 are affected, all batch numbers, distributed worldwide.
The recall was initiated after Landauer received reports that some nanoDots may measure radiation exposure outside the specified accuracy range of plus or minus 5.5%. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which is stimulated by light after radiation exposure and emits fluorescence proportional to the absorbed radiation dose.
Radiation monitoring dosimeters are used in occupational and industrial settings to measure worker radiation exposure.
The recalled product
- Product
- nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Affected units
- 16,820
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.
Part of a larger recall action
This product is one of 38 recalled by Landauer under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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