Device product
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.
Z-2265-2016
Product summary
- Event
- Event 74505
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
device-enforcement:Z-2265-2016
Official wording
Reason: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Code information: all lots are affected
Distribution pattern: US
Derived failure modes
-
Labeling or packaging
labeling and packaging is incorrect