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Class 3 Device Recall DiaSorin AntiHuman IgG Fluorescein Conjugate |
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| Date Initiated by Firm |
January 18, 2005 |
| Date Posted |
April 13, 2005 |
| Recall Status1 |
Terminated 3 on July 22, 2006 |
| Recall Number |
Z-0706-05 |
| Recall Event ID |
31095 |
| Product Classification |
Igg, Fitc, Antigen, Antiserum, Control - Product Code DGK
|
| Product |
DiaSorin Analyte Specific Reagent |
| Code Information |
lot # 926603-08 |
Recalling Firm/
Manufacturer |
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Other |
| Action |
Customers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered. |
| Quantity in Commerce |
1 |
| Distribution |
WA, MA, and Korea |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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