Alere San Diego, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1148-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: February 26, 2013

Date Posted: April 24, 2013

Recall Number: Z-1148-2013

Event ID: 64790

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.

Status: Terminated

Product Quantity: 78 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated