Class 2 Device Recall Boule ConDiff TriLevel

• Date Initiated by Firm: February 24, 2013
• Date Posted: April 09, 2014
• Recall Status: Terminated 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: 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