Z-1744-2018 Class II Terminated
FDA device recall Z-1744-2018 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: 281.
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
- 281
Product Description
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.
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: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2