Z-2936-2020 Class II Ongoing

Recalled by Diasorin Inc. — Stillwater, MN

FDA device recall Z-2936-2020 was initiated by Diasorin Inc. on July 17, 2020 and is designated Class II. Reason for recall: Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value The recall status is ongoing. Affected quantity: 615 units.

Recall Details

Product Type
Devices
Report Date
September 9, 2020
Initiation Date
July 17, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
615 units

Product Description

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 Pattern

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

Code Information

Lot 71440040AA