Home / Recalls / Alere San Diego, Inc. / Z-2268-2016

Z-2268-2016 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

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.

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

Code Information

all lots are affected

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