FDA recall Z-0702-2024

Product

Detector H. Pylori, Catalog Number IHP-30

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.

Key facts

Status

Ongoing

Initiation date

2023-08-25

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0702-2024