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U.S. Department of Health and Human Services

Class 2 Device Recall Dade Actin Activated Cephaloplastin Reagent

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  Class 2 Device Recall Dade Actin Activated Cephaloplastin Reagent see related information
Date Initiated by Firm March 25, 2015
Date Posted June 02, 2015
Recall Status1 Terminated 3 on January 24, 2017
Recall Number Z-1703-2015
Recall Event ID 71273
510(K)Number K760318  
Product Classification Activated partial thromboplastin - Product Code GFO
Product Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
Code Information Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 , expiration dates:10/31/2015, 11/21/2015, 2/16/2016 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.
FDA Determined
Cause 2		 Under Investigation by firm
Action On March 24, 2015 an Urgent Medical Device Recall letter was mailed to all affected customers to notify them about the issue, associated risks, and actions to be taken.
Quantity in Commerce 27501
Distribution Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
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 = GFO and Original Applicant = DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
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