Helicobacter Pylori

H pylori (Peptic ulcer) Test

Distribution without premarket approval/clearance.

Peptic Ulcer Test (H, pylori)

Distribution without premarket approval/clearance.

Detector H. Pylori, Catalog Number IHP-30

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.

VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

H pylori IgG ELISA kit (Qualitative)

Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A

The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M

The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations.

Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)

Kits had parts in them that did not belong in the kit.