# FDA recall Z-0702-2024

> **Immunostics, Inc.** · Class II · device recall initiated 2023-08-25.

## 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

- **Recall number:** Z-0702-2024
- **Recalling firm:** Immunostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-25
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eatontown, NJ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0702-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0702-2024. Source: US FDA. Licensed CC0.

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