Recall Z-0702-2024— Immunostics, Inc.

Name: FDA recall Z-0702-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Class II · Ongoing

Class II FDA medical device recall by Immunostics, Inc., initiated 2023-08-25. It names one FDA 510(k) clearance: K980798. Product: Detector H. Pylori, Catalog Number IHP-30. Reason: 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..

Recalling firm: Immunostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-25
Firm location: Eatontown, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K980798 — BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTPrinceton BioMeditech Corp.·cleared 1998-09-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.