Reported Jan 17, 2024 · Ongoing
Detector H. Pylori, Catalog Number IHP-30
Immunostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Immunostics, Inc. · 38 Industrial Way E Ste 1 · Eatontown, NJ · 07724-3334
Is this the product you have?
- Detector H. Pylori, Catalog Number IHP-30
- Lot codes and dates
- UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4
- Incorrect label Expiration2023-10-31
- Correct Expiration2022-10-31
- Amount recalled
- 10 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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