Recall Z-0702-2024
Immunostics, Inc. · initiated August 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Detector H. Pylori, Catalog Number IHP-30
Codes / lots: UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31
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.
FDA-determined 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
Details
- Recall number
- Z-0702-2024
- Initiated
- August 25, 2023
- Posted by FDA
- January 10, 2024
- Product code
- LYR – Helicobacter Pylori
- Quantity
- 10 kits
- Distribution
- Product distributed to CA and MO.
- Recalling firm
- Immunostics, Inc., Eatontown, NJ