ClearanceBrief
Recall Z-0706-05 ยท DGK Igg, Fitc, Antigen, Antiserum, Control

Diasorin Inc.

DiaSorin Analyte Specific Reagent

DateApr 13, 2005 (initiated Jan 18, 2005)
StatusTerminated
ReasonExpiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
Root causeOther
ActionCustomers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered.
Quantity1
DistributionWA, MA, and Korea
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.