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 er…
- Recall date
- June 22, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2268-2016
- FDA classification
- Class III
- Brand / firm
- Alere San Diego, Inc.
- Sold / distributed
- US
Why it was recalled
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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