FDAFDA · Food and drugs·Recall number Z-0616-2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Published January 3, 2024 · Recall initiated: November 15, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Landauer
- Distributor
- US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
- Lot
- All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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