Detector H. Pylori, Catalog Number IHP-30
Reported: January 17, 2024 Initiated: August 25, 2023 #Z-0702-2024
Product Description
Detector H. Pylori, Catalog Number IHP-30
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.
Details
- Recalling Firm
- Immunostics, Inc.
- Units Affected
- 10 kits
- Distribution
- Product distributed to CA and MO.
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
Detector H. Pylori, Catalog Number IHP-30. Recalled by Immunostics, Inc.. Units affected: 10 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2024. Severity: Moderate. Recall number: Z-0702-2024.
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