Class 2 Device Recall Mainline Confirms Strep A,

• Date Initiated by Firm: November 08, 2006
• Date Posted: September 22, 2008
• Recall Status: Terminated on March 16, 2009
• Recall Number: Z-2427-2008
• Recall Event ID: 49082
• Product Classification: Streptococcusspp serological reagents. - Product Code GTY
• Product: Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 test).
• Code Information: Lot No: 94300.
• FEI Number: 1000160426
• Recalling Firm/ Manufacturer: Mainline Technology, Inc.; 3985 Research Park Dr; Ann Arbor MI 48108-2282
• For Additional Information Contact: 734-930-2043
• Manufacturer Reason for Recall: Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Consignees were notified by phone and follow-up letter on or about 11/6/06 advising them of the problem. Consignees were give the option of returning the product and receiving the correct tip, or keeping the product and adding extra drops. Additional written notice was provide to each consignee.
• Quantity in Commerce: 11,520
• Distribution: Nationwide Distribution.
• 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.