FDAFDA · Food and drugs·Recall number Z-0702-2024
Detector H. Pylori, Catalog Number IHP-30
Published January 17, 2024 · Recall initiated: August 25, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Immunostics, Inc.
- Distributor
- Product distributed to CA and MO.
- Lot
- UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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