Immunostics, Inc. recalls Detector H. Pylori, Catalog Number IHP-30

Recall date

August 25, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0702-2024

FDA classification

Class II

Brand / firm

Immunostics, Inc.

Sold / distributed

Product distributed to CA and MO.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Detector H. Pylori, Catalog Number IHP-30