Landauer nanoDot radiation dosimeter units recalled due to accuracy failure
Landauer is recalling 973 radiation dosimeter units that may not accurately measure radiation exposure due to a potential defect in the light-emitting material used for dose measurement.
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 medical device recall. While no illnesses or injuries have been reported, a radiation dosimeter that measures outside its specified accuracy range presents a direct occupational safety risk—workers could receive undetected radiation exposure.
Plain-English summary
Landauer is recalling 973 units of Calibrate (80 kVp) nanoDot D2DNS radiation dosimeters (Model Numbers 18121-000, 18121-KIT, and 18121-SET) distributed worldwide. These dosimeters are used to monitor radiation exposure in occupational settings by measuring radiation dose with microSTAR readers.
Investigation revealed that some units may fall outside the specified accuracy tolerance of ±5.5% due to a potential defect in the Optical Stimulated Luminescence (OSL) material. The OSL material is designed to emit fluorescence proportional to radiation exposure when stimulated; a non-conformance in this material could result in inaccurate dose measurements.
Individuals and organizations using these dosimeters to monitor worker radiation exposure are potentially affected. Inaccurate dosimeter readings could fail to detect significant radiation exposure, creating an occupational safety risk.
The recalled product
- Product
- Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Affected units
- 973
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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