FDA recall Z-2346-2019

Product

ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

Reason for recall

Residual crystallization of the microplate and recurrent negative controls out of range.

Distribution

Distribution to US states of NC, NH, NY, and OH, and Sweden.

Key facts

Status

Terminated

Initiation date

2019-07-19

Report date

2019-08-28

Termination date

2021-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2346-2019