Recall Z-1060-2013
Polymedco, Inc · initiated February 12, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1060-2013
- Initiated
- February 12, 2013
- Posted by FDA
- April 4, 2013
- Terminated
- February 10, 2016
- Product code
- KHE – Reagent, Occult Blood
- Quantity
- 229,600 test strips
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
- Recalling firm
- Polymedco, Inc, Cortlandt Manor, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1059-2013 Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid…The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being… | 02/12/2013Terminated |