Immunostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0702-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Detector H. Pylori, Catalog Number IHP-30

Product Classification:

Class II

Date Initiated: August 25, 2023

Date Posted: January 17, 2024

Recall Number: Z-0702-2024

Event ID: 93646

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.

Status: Ongoing

Product Quantity: 10 kits

Code Information:

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

Distribution Pattern:

Product distributed to CA and MO.

Voluntary or Mandated:

Voluntary: Firm initiated