Reported Jan 3, 2024 · Completed
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Landauer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Landauer · 2 Science Rd · Glenwood, IL · 60425-1531
Is this the product you have?
- Landauer microSTARii reader, Medical Dosimetry System
- Model Numbers18000-000/18001-000/18007-000
- Lot codes and dates
- All serial numbers.
- Amount recalled
- 584 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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