Recall Z-2501-2010
Inverness Medical Professional Diagnostics · initiated February 12, 2010
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.
Codes / lots: 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.
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 taken
The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.
Details
- Recall number
- Z-2501-2010
- Initiated
- February 12, 2010
- Posted by FDA
- September 25, 2010
- Terminated
- May 14, 2012
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Quantity
- 585 kits
- Distribution
- Distributed Nationwide and to Australia
- Recalling firm
- Inverness Medical Professional Diagnostics, Princeton, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2500-2010 | UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG…Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test… | 02/12/2010Terminated |