Radiation monitoring dosimeters recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters because they may give inaccurate readings. Some units may read outside the acceptable accuracy range.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a medical device used for radiation safety monitoring. While no illnesses or injuries have been reported, the potential non-conformance could result in inaccurate radiation exposure readings, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Landauer is recalling approximately 4,005 Calibrate (Cs-137) nanoDot D2DNS radiation monitoring dosimeters distributed worldwide. These devices are used with microSTAR readers to monitor occupational radiation exposure.
The recall was initiated because some dosimeters may provide inaccurate radiation measurements. Investigation found a potential non-conformance in the optical stimulated luminescence (OSL) material used in the dosimeters, which could cause them to read outside the specified ±5.5% accuracy range.
Affected dosimeters include Model Numbers 04224-000 (EMEA number VINLNAN006), 04224-KIT, and 04224-SET. All batch numbers under UDI/DI 0860003399903 are included in the recall.
The recalled product
- Product
- Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- radiation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 0860003399903
- all batch numbers
Distribution
Distribution scope not specified by the agency.
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