Home / Recalls / Alere San Diego, Inc. / Z-2265-2016

Z-2265-2016 Class III Terminated

Recalled by Alere San Diego, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
August 3, 2016
Initiation Date
June 22, 2016
Termination Date
January 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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.

Distribution Pattern

US

Code Information

all lots are affected

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