Detector H — Class II medical device recall Z-0702-2024
Ongoing recall by Immunostics, Inc., reported 2024-01-17, distributed in CA, MO. Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expir
| Recall number | Z-0702-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immunostics, Inc., Eatontown, NJ, United States |
| Recall initiated | 2023-08-25 |
| Classified | 2024-01-10 |
| Reported by FDA | 2024-01-17 |
| Distributed | CA, MO |
| Quantity | 10 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10722355002023 |
| Lot numbers | 0821132-2, 0821132-3, 0821132-4 |
| Model numbers | IHP-30 |
| Expiration dates | 2022-10-31, 2023-10-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0702-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.