NanoDots radiation dosimeter recalled for potential measurement accuracy issues
Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.
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 a risk-of-harm product—a radiation dosimeter used for occupational safety—where measurement inaccuracy could affect worker protection decisions. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury qualify as High severity.
Plain-English summary
Landauer is recalling NanoDots Model Number 04297-000 radiation monitoring dosimeters because some units may not meet the specified accuracy range of +/-5.5%. These devices measure occupational radiation exposure for use with microSTAR readers.
The recall affects approximately 310 units that were distributed worldwide under UDI/DI 0860003399903 and all batch numbers. Investigation revealed a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which emits fluorescence proportional to radiation exposure when beamed after radiation exposure. If this material is defective, the resulting dose measurements could be inaccurate.
No illnesses or injuries have been reported.
The recalled product
- Product
- NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Affected units
- 310
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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