FDA Medical Device Recalls (openFDA)
Immunostics, Inc.: Detector H. Pylori, Catalog Number IHP-30
- Recall number
- Z-0702-2024
- Recalling firm
- Immunostics, Inc.
- Product
- Detector H. Pylori, Catalog Number IHP-30
- Status
- Open, Classified
- Initiated
- 2023-08-25
- Posted
- 2024-01-10
- Terminated
- not on file
- 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.
- Root cause
- Incorrect or no expiration date
- Action
- 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 technical@immunostics.com
- Quantity
- 10 kits
- Distribution
- Product distributed to CA and MO.
- Lot, serial or model codes
- UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
- 510(k) numbers
- ["K980798"]
- PMA numbers
- not on file
- Product code
- LYR
- Firm FEI
- 2244821
- Firm city
- Eatontown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28