FDAFDA · Food and drugs·Recall number Z-2266-2016
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.
Published August 3, 2016 · Recall initiated: June 22, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alere San Diego, Inc.
- Distributor
- US
- Lot
- all lots are affected
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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