Class 3 Device Recall UCG BetaSlide Monoclonal II

• Date Initiated by Firm: February 12, 2010
• Date Posted: September 25, 2010
• Recall Status: Terminated on May 14, 2012
• Recall Number: Z-2501-2010
• Recall Event ID: 54745
• Product Classification: Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
• Product: UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test is used for the diagnosis of pregnancy.
• Code Information: Code number 16B4; lot numbers 0224099, Exp. 7/9/2010; 0618299, Exp 10/30/2010; 0818039, Exp. 1/11/2011 and 1010168, Exp. 3/20/2010.
• FEI Number: 3003764480
• Recalling Firm/ Manufacturer: Inverness Medical Professional Diagnostics; 2 Research Way; Princeton NJ 08540-6628
• For Additional Information Contact: Inverness Medical Technical Service; 877-441-7440
• Manufacturer Reason for Recall: Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test.
• FDA Determined Cause: Other
• Action: The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.
• Quantity in Commerce: 585 kits
• Distribution: Distributed Nationwide and to Australia
• 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.