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U.S. Department of Health and Human Services

Class 3 Device Recall Boule ConDiff Hematology Control

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  Class 3 Device Recall Boule ConDiff Hematology Control see related information
Date Initiated by Firm August 04, 2010
Date Posted November 05, 2012
Recall Status1 Terminated 3 on August 14, 2014
Recall Number Z-0193-2013
Recall Event ID 63094
510(K)Number K024173  
Product Classification Mixture, hematology quality control - Product Code JPK
Product Boule Con Diff US Tri Pack, 6 Vials.

For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Information Product part 501-605, Lot #1005-549  
Recalling Firm/
Manufacturer		 Clinical Diagnostic Solutions
1800 Nw 65th Ave Ste 2
Plantation FL 33313-4544
For Additional Information Contact Maritza Pastoriza
954-791-1773
Manufacturer Reason
for Recall		 Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
FDA Determined
Cause 2		 Process control
Action Clinical Diagnostic Solutions, Inc. sent a "PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328.
Quantity in Commerce 532 packs
Distribution Nationwide Distribution.
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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