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U.S. Department of Health and Human Services

Class 2 Device Recall DispoSystem for BCT System

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  Class 2 Device Recall DispoSystem for BCT System see related information
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
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/
Dade Behring , Inc.
Rte 896, Glasgow Business Community
Newark DE 19702
For Additional Information Contact Donna A. Wolf
Manufacturer Reason
for Recall
APTT determinations when using affected rotors may lead to incorrectly shortened times
FDA Determined
Cause 2
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

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.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = DADE BEHRING, INC.