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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 Recall
Boule ConDiff Hematology Control
see related information
Date Posted November 05, 2012
Recall Status1 Open
Recall Number Z-0193-2013
Recall Event ID 63094
Premarket Notification
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, Florida 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JPK and Original Applicant = CLINICAL DIAGNOSTIC SOLUTIONS, INC.
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