Home / Recalls / Hyphen BioMed / Z-1743-2018

Z-1743-2018 Class II Terminated

Recalled by Hyphen BioMed — Neuville Sur Oise, N/A

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
60

Product Description

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

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, F1701370P1, F1701370P2

Other recalls by Hyphen BioMed

  • Z-1744-2018 Class II — ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screen (February 5, 2018)
  • Z-1742-2018 Class II — ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitativ (February 5, 2018)
  • Z-1062-2018 Class II — ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the (November 9, 2011)
  • Z-1063-2018 Class II — ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assa (November 9, 2011)