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Alere San Diego, Inc. recalls Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine ery
Recalled August 3, 2016 · FDA recall Z-2268-2016 · 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
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 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 →