Eatontown, NJ, United States
Immunostics, Inc. recalls
1 recall recorded since 2018, most recently on 25 August 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 August 2023
- 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.
- Distribution
- Product distributed to CA and MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0702-2024
- Detector H. Pylori, Catalog Number IHP-30
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.