| Date Initiated by Firm | March 14, 2007 |
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| Date Posted | April 24, 2007 |
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| Recall Status1 |
Terminated 3 on July 15, 2007 |
| Recall Number | Z-0755-2007 |
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| Recall Event ID |
37691 |
| 510(K)Number | K946158 |
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| Product Classification |
In vitro diagnostic - Product Code LLM
|
| Product | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic.
For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285 |
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| Code Information |
3160240B/1 |
Recalling Firm/
Manufacturer |
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
|
Manufacturer Reason
for Recall | A lot to lot inconsistency was noted on kits of ETI EBNA G. |
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FDA Determined
Cause 2 | Other |
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| Action | All consignees will be notified by phone followed by a notification letter sent by fax March 14, 2007. The distributors are instructed to forward the notification to the customers who have received the affected product. |
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| Quantity in Commerce | 203 |
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| Distribution | Nationwide and Canada. |
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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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| 510(K) Database | 510(K)s with Product Code = LLM
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