Class II
Medical Device Recall: Detector H. Pylori, Catalog Number IHP-30
Immunostics, Inc. · August 25, 2023
Reason for Recall
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.
Distribution
Product distributed to CA and MO.
States Affected
CA, MO
Quantity Affected
10 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0702-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.