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Terminated

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.

FDA Recall Z-2501-2010 · Posted 2010-09-25

Recalling FirmInverness Medical Professional Diagnostics
Recall StatusTerminated
Product CodeLCX
Date Initiated2010-02-12
Date Terminated2012-05-14
Product Quantity585 kits

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.

Firm Action

The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.

Root Cause

Other

Distribution Pattern

Distributed Nationwide and to Australia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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