FDA recall Z-1742-2018

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.

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

OH, MD, NC, NY, NH, Canada, Sweden

Key facts

Status

Terminated

Initiation date

2018-02-05

Report date

2018-05-16

Termination date

2018-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Neuville Sur Oise, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2018