Class II — Immunostics, Inc.
| Recalling firm | IMMUNOSTICS, INC. |
|---|---|
| Registered facility | IMMUNOSTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Detector H. Pylori, Catalog Number IHP-30 |
| Quantity | 10 kits |
| Distribution | Product distributed to CA and MO. |
| Initiated | 2023-08-25 |
| Classified | 2024-01-10 |
| Recall number | Z-0702-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Immunostics, Inc. (Z-0702-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93646/
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