Z-2501-2010

UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in...

Name: Z-2501-2010 UCG Beta Slide Monoclonal II is a latex agglutination inhibition slide test for the detection of hCG in...
Creator: Inverness Medical Professional Diagnostics
Published: 2010-02-12
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2010-02-12 / Terminated

FDA source

Inverness Medical Professional Diagnostics began a recall of 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 on 2010-02-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2501-2010
Status: Terminated
Initiated: 2010-02-12
Posted: 2010-09-25
Terminated: 2012-05-14
Recalling firm: Abbott Diagnostics Scarborough, Inc.
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.
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 root cause: 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
Product codes and 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.

Product code LCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)