Class 2 Device Recall BD MAX DNA Extraction Kit DNA1 (Urine/Plasma)

• Date Initiated by Firm: May 24, 2011
• Date Posted: September 16, 2011
• Recall Status: Terminated on October 12, 2011
• Recall Number: Z-3216-2011
• Recall Event ID: 59359
• Product Classification: System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
• Product: BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. ; ; The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. ; Product Quantity Distributed (Int) 21 kits
• Code Information: Lot numbers 110731, 110831, 111011, 111111
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; BD Diagnostic Systems; 7 Loveton Circle; Sparks MD 21152-0999
• For Additional Information Contact: John R. Gerlich; 410-316-4000
• Manufacturer Reason for Recall: Sample results maybe switched between time it was scanned with handheld barcode reader and time it was placed in the sample rack, associating sample results to wrong patient.
• FDA Determined Cause: Nonconforming Material/Component
• Action: BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other inquiries, contact BD Technical Services Dept. 1-800-638-8663.
• Quantity in Commerce: 21 kits
• Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
• 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.