| Date Initiated by Firm | October 26, 2005 |
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| Date Posted | January 20, 2006 |
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| Recall Status1 |
Terminated 3 on March 01, 2006 |
| Recall Number | Z-0408-06 |
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| Recall Event ID |
34011 |
| Product Classification |
Test, Qualitative And Quantitative Factor Deficiency - Product Code GGP
|
| Product | STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method. |
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| Code Information |
Lot 0422671 exp. March 2006. |
Recalling Firm/
Manufacturer |
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
|
| For Additional Information Contact | James Barrow
973-631-1200 Ext. 116 |
|---|
Manufacturer Reason
for Recall | The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range. |
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FDA Determined
Cause 2 | Other |
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| Action | Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter. |
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| Quantity in Commerce | 150 units |
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| Distribution | Product was distributed to 23 direct account customers nationwide. |
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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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