Z-1742-2018 Class II Terminated
FDA device recall Z-1742-2018 was initiated by Hyphen BioMed on February 5, 2018 and is designated Class II. Reason for recall: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. The recall status is terminated (terminated August 16, 2018). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- February 5, 2018
- Termination Date
- August 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product Description
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.
Reason for Recall
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Distribution Pattern
OH, MD, NC, NY, NH, Canada, Sweden
Code Information
Lot numbers: F1701084P2 and F1701084P3