FDAClass IIJanuary 17, 2024

Detector H. Pylori recall: Labeling Error

Detector H. Pylori, Catalog Number IHP-30

Why was Detector H. Pylori 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31

Product
Detector H. Pylori, Catalog Number IHP-30
Recalling firm
Immunostics, Inc.
Quantity
10 kits
Distribution
Product distributed to CA and MO.
Recall date
January 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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