FDA Device recall Z-0702-2024
Detector H. Pylori, Catalog Number IHP-30
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Detector H. Pylori, Catalog Number IHP-30 by Immunostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0702-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-25 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Immunostics |
| Distribution | CA, MO |
Product
Detector H. Pylori, Catalog Number IHP-30
Reason
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.
Identifiers
| code_info | UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0702-2024%22
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