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U.S. Department of Health and Human Services

Class 3 Device Recall Boule Con Diff US Tri Pack

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 Class 3 Recall
Boule Con Diff US Tri Pack
see related information
Date Posted November 02, 2012
Recall Status1 Terminated on August 13, 2014
Recall Number Z-0189-2013
Recall Event ID 63096
Premarket Notification
510(K) Number
K024173 
Product Classification Mixture, Hematology Quality Control - Product Code JPK
Product Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Code Information Product Part 501-605, Lot #1102-575 and Lot # 1102-576
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 Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328. For questions regarding this recall call 954-791-1773.
Quantity in Commerce 623 vials
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
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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