FDA-Device2024-01-17Class II
Detector H. Pylori, Catalog Number IHP-30
Immunostics, Inc.
Hazard
Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
Sold states
Product distributed to CA and MO.
Affected count
10 kits
Manufactured in
38 Industrial Way E Ste 1, Eatontown, NJ, United States
Products
Detector H. Pylori, Catalog Number IHP-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0702-2024Don't want to check this manually?
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