Radiation Dosimeter Recall for Potential Measurement Accuracy Issues
Landauer recalls Calibrate nanoDot radiation dosimeters (Model 03064-OTO) worldwide due to potential inaccuracies. Some units may exceed the ±5.5% accuracy specification, resulting in inaccurate radiation exposure readings.
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 FDA recall for a medical device with a potential measurement accuracy issue. No injuries, illnesses, or deaths have been reported. The hazard is theoretical (potential non-conformance), and per the rubric, recalls with no reported harm and theoretical hazards score at most 3 (High).
Plain-English summary
Landauer is recalling Calibrate (80 kVp) screened nanoDot D2DNS radiation monitoring dosimeters, Model Number 03064-OTO. These devices use UDI/DI 0860003399903 and have been distributed worldwide across all batch numbers.
Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material in some dosimeters. The OSL material emits fluorescence proportional to radiation exposure to measure radiation dose. Some units may be outside the manufacturer's specified accuracy range of ±5.5%.
Inaccurate radiation measurements from these dosimeters could affect the reliability of radiation exposure monitoring.
The recalled product
- Product
- Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
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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