Recall Z-1060-2013 ยท KHE Reagent, Occult Blood
Polymedco, Inc
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
| Date | Apr 4, 2013 (initiated Feb 12, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Polymedco initiated phone calls to clients on 2/12/13. When the contact was made with the client, an URGENT DEVICE RECALL letter and Fax Form were sent by e-mail/fax. Mass mailing of the URGENT DEVICE RECALL letter dated February 12, 2013 and Fax Form was done by First Class USPS on 2/14/13-2/18/13. The recall affects the test strips only. For questions, please contact Polymedco Technical Support at 1-800-431-2123 ext 285. |
| Quantity | 229,600 test strips |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.