FDA recall Z-1499-2018

Product

MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Reason for recall

A component of the kit was found to contain bacterial contamination.

Distribution

Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

Key facts

Status

Terminated

Initiation date

2015-11-03

Report date

2018-05-02

Termination date

2020-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1499-2018