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U.S. Department of Health and Human Services

Class 3 Device Recall UCG BetaSlide Monoclonal II

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  Class 3 Device Recall UCG BetaSlide Monoclonal II see related information
Date Initiated by Firm February 12, 2010
Date Posted September 25, 2010
Recall Status1 Terminated 3 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.
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 2		 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.
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