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U.S. Department of Health and Human Services

Class 2 Device Recall Boule ConDiff TriLevel

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  Class 2 Device Recall Boule ConDiff TriLevel see related information
Date Initiated by Firm February 24, 2013
Date Posted April 09, 2014
Recall Status1 Terminated 3 on August 07, 2014
Recall Number Z-1436-2014
Recall Event ID 67724
510(K)Number K024173  
Product Classification Mixture, hematology quality control - Product Code JPK
Product Boule Con-Diff Tri-Level
Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Information Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
Recalling Firm/
Manufacturer		 Clinical Diagnostic Solutions
1800 Nw 65th Ave Ste 2
Plantation FL 33313-4544
For Additional Information Contact Mr. Patrick G. Saunders
954-791-1773
Manufacturer Reason
for Recall		 Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
FDA Determined
Cause 2		 Under Investigation by firm
Action Clinical Diagnostic Solutions sent a Notification letter dated February 26, 2014 to affected customers. The letter identified the affected product, problem and the actions to be taken. For questions contact Technical Support at 1-800-453-3328.
Quantity in Commerce 3,540
Distribution Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
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 = JPK and Original Applicant = CLINICAL DIAGNOSTIC SOLUTIONS, INC.
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