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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:202820

NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers

Official recall number

Z-2573-2023

Evidence summary

Product code
IYE
Recall status
Completed
Event initiated
July 12, 2023
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2573-2023

Field note

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