FDA-Device2020-09-09Class II

Parvovirus B19 IgG EIA kit Part No. V519IGUS

Diasorin Inc.
Hazard

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

Sold states
NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada
Affected count
615 units
Manufactured in
1951 Northwestern Ave S, N/A, Stillwater, MN, United States
Products
Parvovirus B19 IgG EIA kit Part No. V519IGUS

Official notice

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

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