Landauer nanoDot radiation dosimeters recalled for measurement inaccuracy
Landauer is recalling QC nanoDot radiation dosimeters worldwide due to potential inaccuracy in radiation dose measurements. Some units may read outside the specified ±5.5% accuracy range.
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 with a potential functional defect in measurement accuracy. No hospitalizations or injuries have been reported. The hazard—potential inaccuracy in radiation dose measurement—represents a risk-of-harm scenario where inadequate detection could occur, but actual harm has not yet been documented.
Plain-English summary
Landauer is recalling 2,240 units of the QC (80 kVp) nanoDot D2DNS radiation monitoring dosimeter (models 04218-000, 04218-KIT, and 04218-SET). The product is used with microSTAR readers to measure radiation exposure.
Investigation by Landauer discovered that some nanoDots may potentially be outside the specified accuracy range of ±5.5%. The issue stems from a potential non-conformance in the Optical Stimulated Luminescence (OSL) material. When exposed to radiation, this OSL material is stimulated and emits fluorescence proportional to the dose received; if the material is non-conforming, the resulting measurements may be inaccurate.
The dosimeters were distributed worldwide. The recalled units are identified by UDI/DI 0860003399903 and include all batch numbers. Users should contact Landauer for further instructions regarding the affected dosimeters.
The recalled product
- Product
- QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218-KIT; c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-error
- radiation-exposure
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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