Home / Recalls / Hyphen BioMed / Z-1742-2018

Z-1742-2018 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
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

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-1743-2018 Class II — ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detec (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)