FDA recall Z-1743-2018

Product

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

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-1743-2018