Class 3 Device Recall PhoenixSpec Calibrator & Kit

• Date Initiated by Firm: June 01, 2016
• Create Date: October 25, 2016
• Recall Status: Terminated on November 08, 2016
• Recall Number: Z-0311-2017
• Recall Event ID: 75375
• 510(K)Number: K023301
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
• Code Information: Part/Catalog Number.: 440911, 441951 Lot / Serial Number. :5364776, 5345796
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; BD Diagnostic Systems; Sparks MD 21152-9212
• For Additional Information Contact: 410-316-4000
• Manufacturer Reason for Recall: BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
• FDA Determined Cause: Process control
• Action: All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement
• Quantity in Commerce: 20
• Distribution: BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers. US: AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI. Ex-US: Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam 4 US government sites were contacted
• 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 = LON