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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87682

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 09, 2021
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
INNOVA MEDICAL GROUP, 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

3 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 3

COVID-19 Self-Test Kit *** INNOVA *** 7T

Z-1537-2021
Recall number
Z-1537-2021
Initiated
April 09, 2021
Classification
Class I
Status
Ongoing
Quantity
370 boxes (=2,590 individual tests)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to distributing test kits to customers who were not part of a clinical investigation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to distributing test kits to customers who were not part of a clinical investigation.

Code information

Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792

Distribution pattern

Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.

device · product 2 of 3

For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

Z-1538-2021
Recall number
Z-1538-2021
Initiated
April 09, 2021
Classification
Class I
Status
Ongoing
Quantity
1,945 boxes (=48,625 individual tests)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to distributing test kits to customers who were not part of a clinical investigation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to distributing test kits to customers who were not part of a clinical investigation.

Code information

Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038

Distribution pattern

Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.

device · product 3 of 3

COVID-19 Self-Test Kit *** INNOVA *** 3T

Z-1539-2021
Recall number
Z-1539-2021
Initiated
April 09, 2021
Classification
Class I
Status
Ongoing
Quantity
402 boxes (=1,206 tests)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to distributing test kits to customers who were not part of a clinical investigation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to distributing test kits to customers who were not part of a clinical investigation.

Code information

Catalog Number: 3T Lot Numbers: U2102003 X2012310

Distribution pattern

Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.