Z-2271-2016 Class III Terminated
FDA device recall Z-2271-2016 was initiated by Alere San Diego, Inc. on June 22, 2016 and is designated Class III. Reason for recall: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. The recall status is terminated (terminated January 29, 2018). Affected quantity: N/A.
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
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 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
US
Code Information
all lots are affected