Device product
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.
Z-2268-2016
Product summary
- Event
- Event 74505
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
device-enforcement:Z-2268-2016
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