Landauer nanoDot radiation dosimeters recalled for potential accuracy deviation
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a potential accuracy deviation in the radiation monitoring device's OSL material, representing a theoretical rather than confirmed risk of harm.
Plain-English summary
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters, including Model Numbers 03056-000, 03056-1MO, 03056-3MO, and 03056-KIT, used with microSTAR readers. Approximately 535,643 units distributed worldwide are involved in the recall.
Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the dosimeters. As a result, some nanoDots may provide radiation exposure readings outside the specified accuracy range of +/-5.5%.
The OSL material is exposed to measure radiation and then emits fluorescence proportional to the exposure. The potential defect in this material is the basis for the recall.
The recalled product
- Product
- nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-error
- accuracy-deviation
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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