Class 2 Device Recall Mainline Confirms hCG Urine

• Date Initiated by Firm: August 18, 2008
• Date Posted: January 15, 2009
• Recall Status: Terminated on February 07, 2011
• Recall Number: Z-0531-2009
• Recall Event ID: 49100
• Product Classification: Human Chorionic Gonadotropin Radioimmunoassay - Product Code JHI
• Product: Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.
• Code Information: Lots 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060, 21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703, 23994, 24483, and 25080.
• 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: 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: 33919 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.