Landauer nanoDot Radiation Dosimeter Recall for Accuracy Defect
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
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 or injuries. The potential accuracy defect in radiation monitoring equipment poses risk but no actual harm has been documented, placing it in the Moderate category.
Plain-English summary
Landauer is recalling approximately 211,815 nanoDot D2DNS radiation dosimeters (Model Numbers 18100-000, 18100-1MO, 18100-2MO, and 18100-KIT) worldwide. These personal dosimeters are used with microSTAR readers to measure and monitor radiation exposure for workers in occupational settings.
An investigation by Landauer identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material within the dosimeters. This OSL material fluoresces proportionally to radiation exposure, allowing the microSTAR reader to measure the accumulated radiation dose. Some units may be outside the specified accuracy range of ±5.5%, resulting in inaccurate dose measurements.
Workers and employers using these dosimeters should contact Landauer for assessment and potential replacement of affected units. Inaccurate radiation measurements could result in workers unknowingly receiving unmonitored radiation exposure, which poses a potential occupational health risk.
The recalled product
- Product
- nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Affected units
- 211,815
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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