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LIAISON® Biotrin Control Parvovirus B19 IgG Plus

DIASORIN SPA · Model 311551 · UDI-DI 08056771104036

MYL Prescription
0
510(k) clearances
0
Adverse events
3
Recalls
3
Facilities

Description

Italy manufactured kit.

Recalls

DateFirmReason
2023-10-31Zeus Scientific, Inc.The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its
2023-10-31Zeus Scientific, Inc.The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its
2020-07-17Diasorin Inc.Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.