Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Reported: August 3, 2016 Initiated: June 22, 2016 #Z-2265-2016
Product Description
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Reason for Recall
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- N/A
- Distribution
- US
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.. Recalled by Alere San Diego, Inc.. Units affected: N/A.
Why was this product recalled? ▼
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Low. Recall number: Z-2265-2016.
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