Radiation Monitoring Dosimeter Accuracy Issue Affects nanoDot Devices
Landauer recalled nanoDot C radiation dosimeters due to potential accuracy errors in the optical stimulated luminescence material. Affected units may provide dosimetry readings outside the specified tolerance range of +/-5.5%.
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 no reported hospitalizations, injuries, or deaths. The hazard is potential inaccuracy in a radiation monitoring dosimeter, representing a risk-of-harm with theoretical rather than confirmed actual harm.
Plain-English summary
Landauer issued a recall of nanoDot C radiation monitoring dosimeters (Model 03503-000), which are used with microSTAR readers. These devices are distributed worldwide and all batch numbers are affected, as indicated by UDI/DI 0860003399903.
The recall was initiated after Landauer received reports that some units may operate outside the specified accuracy range of +/-5.5%. Investigation found a potential non-conformance in the optical stimulated luminescence (OSL) material within the dosimeters. This material is designed to emit fluorescence proportional to radiation exposure, allowing measurement of radiation dose.
Due to this non-conformance, affected units may provide inaccurate radiation dosimetry readings.
The recalled product
- Product
- nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- dosimetry-error
- measurement-error
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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