Detector H. Pylori, Catalog Number IHP-30
FDA device recall Z-0702-2024 · posted 2024-01-10 · Open, Classified
Recall details
- Recalling firm
- Immunostics, Inc.
- 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.
- 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
- Root cause
- Incorrect or no expiration date
- Status
- Open, Classified
- Product code
- LYR
- Quantity affected
- 10 kits
- Distribution
- Product distributed to CA and MO.
- Date initiated
- 2023-08-25
- Date posted
- 2024-01-10
- Location
- Eatontown, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST (K980798) | Princeton BioMeditech Corp. | 1998-09-22 |