Home / Recalls / Medical Devices
Alere San Diego, Inc. recalls Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocyt
Recalled August 3, 2016 · FDA recall Z-2269-2016 · Alere San Diego
Hazard
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. · FDA Class III
Units
N/A
Sold at
US
Description
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Product
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 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.
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →