Class 1 Device Recall

• Date Initiated by Firm: July 21, 2003
• Date Posted: August 20, 2003
• Recall Status: Terminated on November 19, 2003
• Recall Number: Z-1094-03
• Recall Event ID: 26884
• 510(K)Number: K984631
• Product Classification: Dna-Reagents, Neisseria - Product Code LSL
• Product: Becton Dickinson's ProbeTec (tm) ET Instrument
• Code Information: Instrument serial numbers 1001-2056
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Circle; Sparks MD 21152
• For Additional Information Contact: Charlotte Duke; 410-316-4258
• Manufacturer Reason for Recall: Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
• FDA Determined Cause: Other
• Action: The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.
• Quantity in Commerce: 1015 units
• Distribution: Product was distributed to domestic and military end users nationwide and international distributors.
• 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 = LSL