Device product
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
Z-1060-2013
Product summary
- Firm
- Polymedco, Inc
- Event
- Event 64537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 229,600 test strips
- Official record key
device-enforcement:Z-1060-2013
Official wording
Reason: The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.
Code information: Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.
Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Derived failure modes
-
Unknown
The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.