| Date Initiated by Firm | February 28, 2007 |
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| Date Posted | May 03, 2007 |
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| Recall Status1 |
Terminated 3 on July 06, 2016 |
| Recall Number | Z-0779-2007 |
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| Recall Event ID |
37762 |
| 510(K)Number | K052124 |
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| Product Classification |
in vitro diagnostic - Product Code GIR
|
| Product | American Diagnostica Inc. ACTICLOT dPT
Reference 824 in vitro diagnostic |
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| Code Information |
Lot Number: 061212 , Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20 |
Recalling Firm/
Manufacturer |
American Diagnostica, Inc.
500 West Ave
Stamford CT 06902-6360
|
Manufacturer Reason
for Recall | Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas |
|---|
FDA Determined
Cause 2 | Other |
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| Action | American Diagnostica notified accounts by letter on 2/28/07 and 3/02/07 and international distributors on 2/28/07. Users are requested to discontinue use and destroy. Kits will be replaced. |
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| Quantity in Commerce | 249 kits |
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| Distribution | Worldwide, including USA, Canada, Germany, UK, Italy, Israel, Greece, and the Netherlands. |
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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 = GIR
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