Atlas FDA

DiaSorin Analyte Specific Reagent

FDA device recall Z-0706-05 · posted 2005-04-13 · Terminated

Recall details

Recalling firm
Diasorin Inc.
Reason for recall
Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
Action taken
Customers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered.
Root cause
Other
Status
Terminated
Product code
DGK
Quantity affected
1
Distribution
WA, MA, and Korea
Date initiated
2005-01-18
Date posted
2005-04-13
Date terminated
2006-07-22
Location
Stillwater, MN

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