Device product
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
Z-1743-2018
Product summary
- Firm
- Hyphen BioMed
- Event
- Event 79797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60
- Official record key
device-enforcement:Z-1743-2018
Official wording
Reason: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Code information: Lot numbers: F1600568P1, F1701370P1, F1701370P2
Distribution pattern: OH, MD, NC, NY, NH, Canada, Sweden
Derived failure modes
-
Labeling or packaging
Incorrect package