FDA recall Z-1063-2018

Product

ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

Reason for recall

A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.

Distribution

Worldwide Distribution - US Distribution and to the countries of : Austria and France.

Key facts

Status

Terminated

Initiation date

2011-11-09

Report date

2018-03-21

Termination date

2018-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Neuville Sur Oise, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2018