Date Initiated by Firm | August 27, 2004 |
Date Posted | October 23, 2004 |
Recall Status1 |
Terminated 3 on May 10, 2005 |
Recall Number | Z-0042-05 |
Recall Event ID |
30005 |
510(K)Number | K011665 |
Product Classification |
System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
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Product | DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies. |
Code Information |
Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832 |
Recalling Firm/ Manufacturer |
Dade Behring , Inc. Rte 896, Glasgow Business Community Newark DE 19702
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For Additional Information Contact | Donna A. Wolf 302-631-0384 |
Manufacturer Reason for Recall | APTT determinations when using affected rotors may lead to incorrectly shortened times |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established. |
Quantity in Commerce | 7140 units |
Distribution | The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN. |
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 = JPA
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