Class 3 Device Recall BD MAX Instrument

• Date Initiated by Firm: May 31, 2013
• Date Posted: July 03, 2013
• Recall Status: Terminated on August 19, 2013
• Recall Number: Z-1662-2013
• Recall Event ID: 65431
• 510(K)Number: K111860
• Product Classification: Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
• Product: BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
• Code Information: Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; BD Diagnostic Systems; 7 Loveton Circle; Sparks MD 21152-0999
• For Additional Information Contact: Gail Claiborne; 410-316-4054
• Manufacturer Reason for Recall: Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
• FDA Determined Cause: Component change control
• Action: Becton Dickinson (BD) notified their customers in the US by phone on May 31, 2013 and by an Urgent Field Correction Action letter dated May 2013. Customers were advised of the affected product, problem and actions to be taken. The letter informed customers that an onsite visit by a BD Service representative is planned to perform a system check so to determine if the instrument is affected. BD's field service team plans to immediately replace the module on site if the affected part is found. For questions contact BD Technical Services Department at 1-800-638-8663.
• Quantity in Commerce: 71 instruments
• Distribution: Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, 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 = NJR