FDA recall Z-1941-2025
Spectral Instruments Inc · Class II · device
Product
Lago X
Reason for recall
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Distribution
US
Key facts
- Status
- Ongoing
- Initiation date
- 2025-05-13
- Report date
- 2025-06-25
- Voluntary/Mandated
- FDA Mandated
- Location
- Tucson, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1941-2025