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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 Systemsee related information
Date Initiated by FirmAugust 27, 2004
Date PostedOctober 23, 2004
Recall Status1 Terminated 3 on May 10, 2005
Recall NumberZ-0042-05
Recall Event ID 30005
510(K)NumberK011665 
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
ProductDispoSystem 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
For Additional Information ContactDonna 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
ActionThe 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 Commerce7140 units
DistributionThe product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JPA
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