Recall Z-2936-2020— Diasorin Inc.
Class II · Ongoing
Class II FDA medical device recall by Diasorin Inc., initiated 2020-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Parvovirus B19 IgG EIA kit Part No. V519IGUS. Reason: Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value.
- Recalling firm
- Diasorin Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-07-17
- Firm location
- Stillwater, MN, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.