Landauer nanoDot radiation dosimeter recalled for potential measurement inaccuracy
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may measure radiation exposure inaccurately, potentially outside the specified +/-5.5% accuracy range. The issue involves the optical stimulated luminescence material used to detect radiation.
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 involving a radiation measurement device with potential accuracy issues. Inaccurate radiation dose measurements present a risk of harm, as readings may fall outside the specified +/-5.5% accuracy range.
Plain-English summary
Landauer is recalling the Calibrate (Cs-137) screened nanoDot D2DNS radiation monitoring dosimeter (Model 03065-OTO) worldwide. Some units may measure radiation exposure inaccurately, with readings potentially falling outside the specified +/-5.5% accuracy range. The recall stems from a potential non-conformance in the optical stimulated luminescence (OSL) material, the component responsible for detecting and measuring radiation exposure.
The recall affects all batch numbers of this dosimeter, identified by UDI/DI 0860003399903. The devices are used with microSTAR readers to monitor radiation exposure in occupational and medical settings.
Consumers and healthcare facilities should discontinue use of affected units and contact Landauer for further information or replacement options. Inaccurate radiation dose readings could compromise exposure assessments and affect occupational radiation safety monitoring.
The recalled product
- Product
- Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
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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