Z-2270-2016 Class III Terminated
FDA device recall Z-2270-2016 was initiated by Alere San Diego, Inc. on Jun 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 Jan 29, 2018).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 3, 2016
- Initiation Date
- Jun 22, 2016
- Termination Date
- Jan 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2270-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026