Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Signify Mono (Whole Blood Recalled by Alere San Diego, Inc. Due to The Positive Control information referencing human plasma as...
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
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.
Quantity: N/A
Why Was This Recalled?
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Where Was This Sold?
US
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