Alere San Diego, Inc. recalls Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to…
- Recall date
- June 22, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2266-2016
- 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
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, 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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