Class 2 Device Recall BD Biosciences Trucount(TM) tubes

• Date Initiated by Firm: June 24, 2016
• Create Date: July 21, 2016
• Recall Status: Terminated on December 02, 2016
• Recall Number: Z-2252-2016
• Recall Event ID: 74537
• 510(K)Number: K970836
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
• Code Information: Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)
• FEI Number: 2916837
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Biosciences; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: Melissa J. Quinn; 408-954-6080
• Manufacturer Reason for Recall: One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.
• FDA Determined Cause: Packaging process control
• Action: Urgent Product Correction notifications letters were sent on June 24, 2016 to all affected customers. Letters identify the issue and product and provide illustrations of the Kit Box and pouch labels. Correction letters identified the issue and the product involved with photos of product labels. BD letters states that they want to reinforce the need to visually inspect the desiccant contained in each pouch . If the desiccant has turned from blue to lavender, discard the remaining tubes. The acknowledgement form should be completed and returned regardless if any inventory remains. If you require further assistance, please contact BD Customer Support at 855.236.2772 (prompt 3) in the Unites States. For customers outside the US, contact your local BD Biosciences representative or distributor
• Quantity in Commerce: 328 US, 516 International
• Distribution: USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile
• 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 = GKZ