Reported Sep 20, 2023 · Completed

NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set -…

Landauer

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Landauer · 2 Science Rd · Glenwood, IL · 60425-1531

Is this the product you have?

8 of 8 products

Products covered by this recall
#Product as published
1BC30023, description: QC Set For Microstar Dots
2BC30083, description: nanoDot QC Set - 80kVp - Sale
3BC30084, description: nanoDot QC Set - 80kVp - No Charge
4BC30088, description: nanoDot Calibration Set - 80kVp - No Charge
5BC30095, description: Dot, D1DNN, in carrier sealed in bag
6BC30110, description: Calibration set, nanoDot
7BC30141, description: nanoDot QC Set - Cs137 - Sale
8BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers
Lot codes and dates
  • UDI/DI 0860003399903, all batch numbers
Amount recalled
18333 units

This recall covers 38 products

The agency filed one notice per product. You are reading one of them; the other 37 are below.

25 more are in the archive.

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.