Z-0702-2024Class II

Detector H. Pylori, Catalog Number IHP-30

Name: Z-0702-2024 Detector H. Pylori, Catalog Number IHP-30
Creator: Immunostics, Inc.
Published: 2023-08-25
License: https://open.fda.gov/license/

Immunostics, Inc. / initiated 2023-08-25 / Open, Classified / root cause: labeling and UDI

FDA source

Immunostics, Inc. began a recall of Detector H. Pylori, Catalog Number IHP-30 on 2023-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0702-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-25
Posted: 2024-01-10
Recalling firm: Immunostics, Inc.
Product: Detector H. Pylori, Catalog Number IHP-30
Product code: LYR Helicobacter Pylori
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: On August 25, 2023, the firm initiated the recall with its distributor, who in turn notified affected customers on September 6, 2023. Customers were instructed to dispose of the product and submit a response form directly to Immunostics, the recalling firm. Customers may contact Immunostics by calling toll free at 1800-722-7505, Monday through Thursday, 8:00 AM to 4:30 PM, Eastern Time and Friday 8:00 AM to 4:00 PM Eastern Time or via email at [email protected]
Quantity in commerce: 10 kits
Distribution: Product distributed to CA and MO.
Product codes and lots: UDI-DI 10722355002023 Lots 0821132-2 0821132-3 0821132-4 Incorrect label Expiration: 2023-10-31 Correct Expiration: 2022-10-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0702-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0702-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code LYR

K980798Class IBiosign H. Pylori Wb-New One-Step Anti-H. Pylori Antibody TestPrinceton BioMeditech Corp. / cleared 1998-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)