Detector H. Pylori, Catalog Number IHP-30
FDA Recall Z-0702-2024 · Posted 2024-01-10
Recalling FirmImmunostics, Inc.
Recall StatusOpen, Classified
Product CodeLYR
Date Initiated2023-08-25
Product Quantity10 kits
Reason for Recall
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.
Firm 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 [email protected]
Root Cause
Incorrect or no expiration date
Distribution Pattern
Product distributed to CA and MO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.