Ami HTX (Spectral Instruments) – Label Mismatch (2025)
Labeling discrepancies may cause minor documentation inconsistencies on medical device labels.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ami HTX.
Brand
Spectral Instruments Inc
Lot Codes / Batch Numbers
Accession number 2510780-000
Products Sold
Accession number 2510780-000
Spectral Instruments Inc is recalling Ami HTX. due to 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 F. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Sent packets by Fed-Ex, containing corrected physical labels to all affected customers who possess either Lago X or AMI HTX instruments shipped before 01/01/2025.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026