FDA recall Z-2574-2018

Product

Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

Reason for recall

Contains a gel-like contaminant that may affect product performance.

Distribution

AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI

Key facts

Status

Terminated

Initiation date

2018-01-05

Report date

2018-08-08

Termination date

2019-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2574-2018