Landauer nanoDot radiation dosimeters potentially outside accuracy specifications
Landauer is recalling nanoDot radiation dosimeters due to a potential manufacturing defect in the optical measurement material. Some units may fall 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: Radiation monitoring dosimeters are risk-of-harm products, and a potential manufacturing non-conformance could result in inaccurate dose recording, affecting occupational radiation exposure monitoring. No illnesses or injuries have been reported, but dosimeter inaccuracy poses risk of undetected worker radiation exposure.
Plain-English summary
Landauer is recalling certain Calibrate (Cs-137) nanoDot D2DNS radiation monitoring dosimeters (model numbers 18125-000, 18125-KIT, and 18125-SET) used with microSTAR readers. Investigation revealed a potential non-conformance in the Optical Stimulated Luminescence (OSL) material, which detects and measures radiation exposure.
Approximately 13,294 units have been distributed worldwide. The affected products carry UDI/DI 0860003399903 and include all batch numbers. Due to the potential non-conformance, some dosimeters may not maintain the specified accuracy range of ±5.5%.
Radiation dosimeters are used to monitor occupational exposure to ionizing radiation. Inaccurate dosimeters could fail to correctly record radiation dose, potentially resulting in undetected radiation exposure to workers. No illnesses or injuries have been reported.
The recalled product
- Product
- Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Affected units
- 13,294
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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