Immunostics, Inc.: Detector H. Pylori, Catalog Number IHP-30

Hazard

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 from the source

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. Distribution: Product distributed to CA and MO. Quantity: 10 kits Lot/code info: UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31

UPC codes

10722355002023

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.