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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86516

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

Open FDA event record

Event summary

Timeline bucket
October 01, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Epitope Diagnostics, 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

EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

Z-0426-2021
Recall number
Z-0426-2021
Initiated
October 01, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Epitope Diagnostics, Inc.
Quantity
2886

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

Code information

Lot Numbers: P826, P815, P796, P776

Distribution pattern

U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.