Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The Recalled by Alere San Diego, Inc. Due to Alere San Diego is recalling the Clearview Mononucleosis...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alere San Diego, Inc. directly.
Affected Products
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.
Quantity: 78 kits
Why Was This Recalled?
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alere San Diego, Inc.
Alere San Diego, Inc. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report