Ami HTX recall: Labeling Error
Ami HTX.
Why was Ami HTX recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Accession number 2510780-000
- Product
- Ami HTX.
- Recalling firm
- Spectral Instruments Inc
- Quantity
- 34
- Distribution
- US
- Recall date
- June 25, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)