Detector H. Pylori Test (Immunostics) – incorrect expiration date (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Detector H. Pylori, Catalog Number IHP-30
Brand
Immunostics, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
Immunostics, Inc. is recalling Detector H. Pylori, Catalog Number IHP-30 due to 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 pro. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MO
Page updated: Jan 10, 2026