Landauer recalls Calibrate nanoDot D2DNS radiation dosimeters with model numbers 18121-000, 18121-KIT, and 18121-SET due to potential accuracy problems outside +/-5.5% range.
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 may not be within the specified accuracy range of +/-5.5%. This could lead to incorrect radiation exposure readings, which might affect safety decisions.
The dosimeters may have a non-conformance in the Optical Stimulated Luminescence (OSL) material that affects their accuracy. This could cause readings to be outside the specified +/-5.5% range, potentially leading to incorrect radiation exposure assessments.
Radiation monitoring professionals and users of the Calibrate nanoDot D2DNS dosimeters with model numbers 18121-000, 18121-KIT, or 18121-SET are likely affected. Those using these devices for radiation safety monitoring are at the highest risk.
Check for model numbers 18121-000, 18121-KIT, or 18121-SET on the Calibrate nanoDot D2DNS radiation dosimeters. These devices were sold with UDI/DI 0860003399903 and all batch numbers.
Identify if your Calibrate nanoDot D2DNS has model numbers 18121-000, 18121-KIT, or 18121-SET.
Landauer received reports that some nanoDots may be outside the specified accuracy range of +/-5.5% due to a potential non-conformance in the OSL material.
Model numbers 18121-000, 18121-KIT, and 18121-SET are affected.
The recall does not require immediate stop use; however, affected users should check model numbers and consider the potential accuracy issues.
We’ve drafted a message you can send Landauer to request your refund or repair — edit it as you like.
Subject: Recall Z-2565-2023 — Landauer Landauer Hello, I own a Landauer that is covered by recall Z-2565-2023 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.
