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Recall Observatory FDA recall evidence

Device product

Detector H. Pylori, Catalog Number IHP-30

Z-0702-2024

August 25, 2023

Class II

Product summary

Firm
Immunostics, Inc.
Event
Event 93646
Status
Ongoing
Classification
Class II
Quantity
10 kits
Official record key
device-enforcement:Z-0702-2024

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.