Landauer recalls Calibrate nanoDot D2DNS radiation dosimeters with model numbers 18125-000, 18125-KIT, and 18125-SET due to potential accuracy deviations beyond specified range. Affected units may not measure radiation exposure correctly.
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.
Landauer is recalling certain Calibrate nanoDot D2DNS radiation dosimeters because they might not measure radiation exposure accurately. This could lead to incorrect readings, which might affect safety decisions in radiation monitoring.
The nanoDots may have a non-conformance in the Optical Stimulated Luminescence (OSL) material that affects their accuracy. This could cause the device to read radiation exposure levels outside the specified +/-5.5% range, potentially leading to incorrect safety assessments.
Radiation monitoring professionals and users of the Calibrate nanoDot D2DNS dosimeters with model numbers 18125-000, 18125-KIT, or 18125-SET are likely affected. Those using these devices for radiation safety checks may be at risk of inaccurate measurements.
Check for model numbers 18125-000, 18125-KIT, or 18125-SET on the Calibrate nanoDot D2DNS radiation dosimeters. These units were sold with UDI/DI 0860003399903 and specific batch numbers.
Look for model numbers 18125-000, 18125-KIT, or 18125-SET on the device.
Landauer received reports that some nanoDots may be outside the specified accuracy range of +/-5.5%. Investigation found a potential non-conformance in the OSL material.
Model numbers 18125-000, 18125-KIT, and 18125-SET are affected.
The recall does not specify a remedy, so no action is required beyond checking if your device has the affected model numbers.
We’ve drafted a message you can send Landauer to request your refund or repair — edit it as you like.
Subject: Recall Z-2566-2023 — Landauer Landauer Hello, I own a Landauer that is covered by recall Z-2566-2023 from Landauer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.