| Date Initiated by Firm | June 20, 2005 |
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| Date Posted | August 30, 2005 |
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| Recall Status1 |
Terminated 3 on August 30, 2005 |
| Recall Number | Z-1422-05 |
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| Recall Event ID |
32714 |
| Product Classification |
System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
|
| Product | STA-R blood coagulation analyzer. Catalog Number 57160. |
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| Code Information |
All units distributed under Catalog Number 57160. |
Recalling Firm/
Manufacturer |
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
|
| For Additional Information Contact | James Barrow
973-631-1200 |
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Manufacturer Reason
for Recall | Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process. |
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FDA Determined
Cause 2 | Other |
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| Action | Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned. |
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| Quantity in Commerce | 215 units |
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| Distribution | Units were distributed to clinics and hospitals 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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