Recall Z-2501-2010 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Inverness Medical Professional Diagnostics
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.
| Date | Sep 25, 2010 (initiated Feb 12, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010. |
| Quantity | 585 kits |
| Distribution | Distributed Nationwide and to Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.