nanoDot A recall
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Why was nanoDot A recalled?
LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 0860003399903, all batch numbers
- Product
- nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
- Recalling firm
- Landauer
- Quantity
- 16820 units
- Distribution
- Worldwide
- Recall date
- September 20, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)