Recall Z-0702-2024 ยท LYR Helicobacter Pylori
Immunostics, Inc.
Detector H. Pylori, Catalog Number IHP-30
| Date | Jan 10, 2024 (initiated Aug 25, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST Princeton BioMeditech Corp., Sep 22, 1998 |