FDA Device recall Z-2269-2016
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively a…
- FDA Device
- Class III
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class III recall of Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively a… by Alere San Diego, citing the Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2269-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-22 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alere San Diego |
| Distribution | n/a |
Product
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 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
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Identifiers
| code_info | all lots are affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2269-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.