Landauer microSTARii reader recalled for measurement inaccuracy
Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.
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 an FDA Class II recall of a measurement-accuracy device where no illnesses, injuries, or deaths have been reported. The hazard is potential inaccuracy in radiation dosimetry measurements, which poses a risk of harm if undetected. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Landauer has recalled 584 microSTARii readers, which are medical dosimetry systems used to measure radiation exposure. The recalled readers may provide inaccurate dose measurements through two mechanisms: the reader's LED beam profile may interact with nanoDot dosimeters in ways that affect measurement accuracy, and debris formed from normal drawer operation may alter the reader's response characteristics.
The measurement inaccuracy may not be apparent during routine use and may not be detectable unless quality control tests using known-dose standards are performed regularly. The affected readers have been distributed in the United States and internationally, including Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Republic of Korea, Taiwan, Thailand, and Vietnam. All serial numbers of the affected models (18000-000, 18001-000, and 18007-000) are included in this recall.
The recalled product
- Product
- Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
- Manufacturer
- Landauer
- Hazard
- measurement-inaccuracy
- calibration-drift
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 (1)
- All serial numbers.
Distribution
Distribution scope not specified by the agency.
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