Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2563-2023 — nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers

U.S. FDA — Device Enforcement · United States · 2023-07-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2563-2023
Date of alert
2023-07-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Landauer
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0860003399903
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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