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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64790
Product Type Devices
Status Ongoing
Recalling Firm Alere San Diego, Inc.
City San Diego
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016. Class III Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results. 78 kits Z-1148-2013