UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in urine. This test
FDA device recall Z-2501-2010 · posted 2010-09-25 · Terminated
Recall details
- Recalling firm
- Inverness Medical Professional Diagnostics
- 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.
- Action taken
- The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCX
- Quantity affected
- 585 kits
- Distribution
- Distributed Nationwide and to Australia
- Date initiated
- 2010-02-12
- Date posted
- 2010-09-25
- Date terminated
- 2012-05-14
- Location
- Princeton, NJ
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