Device product
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
Z-1742-2018
Product summary
- Firm
- Hyphen BioMed
- Event
- Event 79797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-1742-2018
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: F1701084P2 and F1701084P3
Distribution pattern: OH, MD, NC, NY, NH, Canada, Sweden
Derived failure modes
-
Labeling or packaging
Incorrect package