| | Class 3 Device Recall DiaSorin AntiHuman IgG Fluorescein Conjugate |  |
| Date Initiated by Firm | January 18, 2005 |
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| Date Posted | April 13, 2005 |
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| Recall Status1 |
Terminated 3 on July 22, 2006 |
| Recall Number | Z-0706-05 |
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| Recall Event ID |
31095 |
| Product Classification |
Igg, Fitc, Antigen, Antiserum, Control - Product Code DGK
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| Product | DiaSorin Analyte Specific Reagent |
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| Code Information |
lot # 926603-08 |
Recalling Firm/
Manufacturer |
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
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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. |
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FDA Determined
Cause 2 | Other |
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| Action | Customers were notified of the incorrect expiration date and instructed to destroy the vials with the incorrect date and product replacement was offered. |
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| Quantity in Commerce | 1 |
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| Distribution | WA, MA, and Korea |
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| 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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