Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
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: FDA Class II recall of a risk-of-harm medical device where measurement accuracy is essential to worker radiation safety. No illnesses or injuries have been reported; the hazard is real but currently theoretical, fitting the criterion for score 3.
Plain-English summary
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters (Model Numbers 03057-1MO, 03057-3MO, 03057-OTO, 03057-SMO) due to a potential non-conformance in the Optical Stimulated Luminescence (OSL) material. The issue may cause some dosimeters to read outside the specified ±5.5% accuracy range, meaning radiation exposure measurements may not be reliable.
The recall affects approximately 18,638 units distributed worldwide. Radiation dosimeters are critical tools for monitoring worker exposure in medical, industrial, and research settings. Inaccurate readings could result in workers receiving more radiation exposure than documented, or protection levels being incorrectly recorded.
Facilities using nanoDot dosimeters with the affected model numbers should contact Landauer for instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-error
- radiation-monitoring
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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