[Recalled] nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers — LANDAUER received reports indicating that some nanoDots may potentially be outs… | FDA 2023-07-12
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers |
|---|---|
| Brand / manufacturer | Landauer |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2563-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 July 2023 |
| EAN / barcode | 0860003399903 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.