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Recall Observatory FDA recall evidence

Device product

Parvovirus B19 IgG EIA kit Part No. V519IGUS

Z-2936-2020

July 17, 2020

Class II

Product summary

Firm
Diasorin Inc.
Event
Event 86152
Status
Ongoing
Classification
Class II
Quantity
615 units
Official record key
device-enforcement:Z-2936-2020

Official wording

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

Code information: Lot 71440040AA

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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