FDA recall Z-2936-2020

Product

Parvovirus B19 IgG EIA kit Part No. V519IGUS

Reason for recall

Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

Distribution

NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada

Key facts

Status

Ongoing

Initiation date

2020-07-17

Report date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stillwater, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2936-2020