Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance
Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated 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 Class II medical device recall involving potential measurement inaccuracy in radiation dosimeters. No injuries or illnesses are reported in the source documentation. The hazard is theoretical—a potential non-conformance in materials that may affect readings—placing it at High level as a risk-of-harm product without confirmed injury.
Plain-English summary
Landauer is recalling 135 nanoDot D2DNS radiation dosimeters (Model 03034-OTO), radiation monitoring devices distributed worldwide. These dosimeters measure occupational radiation exposure using optical stimulated luminescence (OSL) technology.
Investigation identified a potential non-conformance in the OSL material used in these dosimeters. This non-conformance may cause some units to read outside the specified accuracy range of ±5.5%. As a result, affected dosimeters may not accurately measure radiation exposure.
The recall affects occupational radiation workers and facilities worldwide that use these dosimeters for radiation monitoring.
The recalled product
- Product
- nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- Affected units
- 135
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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