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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74843

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

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Event summary

Timeline bucket
July 20, 2016
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
OraSure Technologies, 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

OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.

Z-2403-2016
Recall number
Z-2403-2016
Initiated
July 20, 2016
Classification
Class I
Status
Terminated
Quantity
3,075 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.

Code information

Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

Distribution pattern

Distributed to one customer only in US state of Georgia.