Radiation monitoring dosimeter accuracy issue prompts FDA Class II recall
Landauer is recalling 427 nanoDot radiation monitoring dosimeters that may provide inaccurate radiation exposure readings. Some units may fall outside the specified ±5.5% accuracy range due to a manufacturing issue.
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 an FDA Class II recall involving a medical device used for radiation exposure monitoring. Although no illnesses or injuries have been reported, inaccurate radiation measurement represents a risk of harm to users who depend on these dosimeters for radiation monitoring.
Plain-English summary
Landauer is recalling 427 QC (80 kVp) nanoDot D2DNS radiation monitoring dosimeters (models 18131-000, 18131-KIT, 18131-SET). These devices have been distributed worldwide and are used with microSTAR readers to monitor radiation exposure.
The recall was initiated after FDA received reports indicating that some nanoDots may measure radiation exposure outside the specified accuracy range of ±5.5%. Investigation revealed a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which measures radiation exposure and emits fluorescence proportional to the dose received.
Units are identified by UDI/DI 0860003399903, covering all batch numbers. Users of these dosimeters may not obtain accurate readings of their radiation exposure levels.
The recalled product
- Product
- QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- radiation-dosimetry
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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