FDA Medical Device Recalls (openFDA)
Inverness Medical Professional Diagnostics: UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy.
- Recall number
- Z-2500-2010
- Recalling firm
- Inverness Medical Professional Diagnostics
- Product
- UCG Slide Test; Rapid latex agglutination inhibition slide test for the detection of hCG in urine. Used in the diagnosis of pregnancy.
- Status
- Terminated
- Initiated
- 2010-02-12
- Posted
- 2010-09-25
- Terminated
- 2012-05-14
- 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
- 1052 kits
- Distribution
- Distributed Nationwide and to Australia
- Lot, serial or model codes
- Code number 15L3; lot numbers 0115299, Exp. 4.12.2010; 0632299, Exp. 7/30/2010; 0811039, Exp. 10/20/2009; Code number 15L5; lot numbers 0135029, Exp. 3.4.2010; 0221099, Exp. 4/12/2010; 0311179, Exp 5/27/2010; 0634299, Exp. 7/30/2010 and 0814039, Exp. 10/20/2010; Code number 15L8: lot numbers: 0136029, Exp. 3/4/2010; 0220099, Exp. 04/12/2010; 0627299, Exp. 07/30/2010; 0817039, Exp. 10/20/2010.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LCX
- Firm FEI
- 3003764480
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28