Class 2 Device Recall Mainline Confirms Strep A

• Date Initiated by Firm: August 18, 2008
• Date Posted: January 15, 2009
• Recall Status: Terminated on February 07, 2011
• Recall Number: Z-0525-2009
• Recall Event ID: 49100
• Product Classification: Human Chorionic Gonadotropin Radioimmunoassay - Product Code JHI
• Product: Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.
• Code Information: Cat. # 3030-20: Lots 94355, 94385, 94395, 94415, 94445, 94455, 94485, 94505, 94545, 94585, and 94595. Cat. # 3030-40: Lots 94350, 94370, 94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590, 94610, 94620, 94630, and 94880.
• 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: Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
• FDA Determined Cause: PMA
• Action: Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08.
• Quantity in Commerce: 3713 kits
• Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
• 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.