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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93646

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 25, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Immunostics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Detector H. Pylori, Catalog Number IHP-30

Z-0702-2024
Recall number
Z-0702-2024
Initiated
August 25, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Immunostics, Inc.
Quantity
10 kits

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

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.

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.