Detector H. Pylori, Catalog Number IHP-30 recallZ-0702-2024 · Immunostics, Inc. · initiated Aug 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Immunostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Incorrect or no expiration date
What the company is doing
On August 25, 2023, the firm initiated the recall with its distributor, who in turn notified affected customers on September 6, 2023. Customers were instructed to dispose of the product and submit a response form directly to Immunostics, the recalling firm. Customers may contact Immunostics by calling toll free at 1800-722-7505, Monday through Thursday, 8:00 AM to 4:30 PM, Eastern Time and Friday 8:00 AM to 4:00 PM Eastern Time or via email at [email protected]
Recall details
- Recall number
- Z-0702-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 25, 2023
- Posted by the FDA
- Jan 10, 2024
- Recalling firm
- Immunostics, Inc.
- Quantity
- 10 kits
- Product code
- LYR
- FDA submissions
- K980798
- Distribution
- Product distributed to CA and MO.
Product description
Detector H. Pylori, Catalog Number IHP-30
Code information (models, lots, serial numbers)
UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Detector H. pylori IHP-30Immunostics Company, Inc · Helicobacter pylori1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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