Detector H. Pylori, Catalog Number IHP-30
This recall is currently active, issued January 10, 2024. It was issued by Immunostics, Inc..
- Company
- Immunostics, Inc.
- Recall Initiated
- August 25, 2023
- Posted
- January 10, 2024
- Recall Number
- Z-0702-2024
- Quantity
- 10 kits
- Firm Location
- Eatontown, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Product distributed to CA and MO.
Lot / Code Info
UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
Root Cause
Incorrect or no expiration date
Action Taken
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