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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced DDimer

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  Class 2 Device Recall Advanced DDimer see related information
Date Initiated by Firm July 29, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on March 01, 2006
Recall Number Z-0172-06
Recall Event ID 32887
510(K)Number K041438  
Product Classification Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
Product Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
Code Information Catalog number OQWM
Recalling Firm/
Dade Behring , Inc.
500 GBC Dr., Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Aydee Crawford
Manufacturer Reason
for Recall
Reports of false negative results on Sysmex Coagulation System.
FDA Determined
Cause 2
Action On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.
Quantity in Commerce 2987 units
Distribution The product was shipped to medical facilities nationwide.
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 = DAP and Original Applicant = DADE BEHRING, INC.