Landauer Radiation Dosimeter Recalled for Potential Measurement Inaccuracy
Landauer is recalling 1,880 units of the Constancy nanoDot D2DNN radiation dosimeter due to a potential non-conformance that may cause inaccurate radiation readings. The devices were distributed worldwide.
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 medical device used for occupational radiation safety where potential measurement inaccuracy presents a risk to worker exposure assessment, but no illnesses or injuries have been reported and the hazard is theoretical.
Plain-English summary
Landauer is recalling 1,880 units of the Constancy (Cs-137) nanoDot D2DNN radiation monitoring dosimeter. The device is used to measure radiation exposure in occupational settings.
Reports indicated that some nanoDots may provide readings outside the specified accuracy range of ±5.5%. Investigation identified a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which converts radiation exposure into a fluorescent signal for measurement by microSTAR readers.
The recall affects all batch numbers of Model Numbers 18155-000 (EMEA number VKITCON001) and 18155-KIT, identified by UDI/DI 0860003399903. Distribution was worldwide.
Users who have these dosimeters should contact Landauer for information about this recall.
The recalled product
- Product
- Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Category
- Medical Device — Dosimetry
- Hazard
- measurement-inaccuracy
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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