Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Class II medical device recall with a safety-relevant defect in a radiation dosimeter. Measurement inaccuracy could affect radiation protection adequacy. No injuries or illnesses reported, and the defect is described as potential rather than confirmed.
Plain-English summary
Landauer is recalling the nanoDot D2DXS radiation monitoring dosimeter (Model Numbers 03063-1MO, 03063-3MO, 03063-OTO, and 03063-SMO). The recall involves approximately 68,007 units distributed worldwide.
The recalled dosimeters may not accurately measure radiation exposure. Investigation found a potential non-conformance in the Optical Stimulated Luminescence (OSL) material used in the device. Some units may fall outside the specified accuracy range of ±5.5%.
No injuries or illnesses have been reported. Users who have these dosimeters should contact Landauer for further information.
The recalled product
- Product
- nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Category
- Medical Device
- Affected units
- 68,007
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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