Landauer 2024-01-03 Health serious FDA
Health · FDA · Recall #FDA-Z-0616-2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: … Recall
Issued January 3, 2024 · Landauer
In January 2024, Landauer recalled the Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Landauer to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Landauer
- Category
- Health
- Recall date
- January 3, 2024
- Units affected
- Not reported
- Sold at
- US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
- Recall number
- FDA-Z-0616-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Landauer has 10 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.