Radiation Dosimeter Accuracy Issue Recall for nanoDot D2DNS
Landauer is recalling nanoDot D2DNS radiation dosimeters due to potential measurement inaccuracy. Some units may read outside the specified +/-5.5% accuracy range.
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 Class II recall affecting a risk-of-harm product. Inaccurate radiation dosimeter readings could result in inadequate radiation exposure assessment, though no illnesses or injuries have been reported to date.
Plain-English summary
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters (Model Numbers 03055-1MO, 03055-3MO, 03055-OTO, and 03055-SMO) due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material. This material is responsible for emitting fluorescence proportional to radiation exposure when read by microSTAR readers.
Some recalled units may measure radiation exposure outside the specified accuracy range of +/-5.5%. This could result in inaccurate dose readings for radiation monitoring purposes.
Approximately 60 units were distributed worldwide. If you use these dosimeters for radiation monitoring, contact Landauer to determine if your units are affected and to obtain corrective action.
The recalled product
- Product
- nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Affected units
- 60
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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