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.
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 7
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information
all lots are affected
Distribution pattern
US
device · product 2 of 7
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information
all lots are affected
Distribution pattern
US
device · product 3 of 7
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information
all lots are affected
Distribution pattern
US
device · product 4 of 7
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information
all lots are affected
Distribution pattern
US
device · product 5 of 7
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information
all lots are affected
Distribution pattern
US
device · product 6 of 7
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information
all lots are affected
Distribution pattern
US
device · product 7 of 7
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
