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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64790

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

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Event summary

Timeline bucket
February 26, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Alere San Diego, 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

IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

Z-1148-2013
Recall number
Z-1148-2013
Initiated
February 26, 2013
Classification
Class III
Status
Terminated
Recalling firm
Alere San Diego, Inc.
Quantity
78 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

Code information

The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.

Distribution pattern

Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia