Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human
FDA device recall Z-1059-2013 · posted 2013-04-04 · Terminated
Recall details
- Recalling firm
- Polymedco, Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KHE
- Quantity affected
- 355,350 test strips
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
- Date initiated
- 2013-02-12
- Date posted
- 2013-04-04
- Date terminated
- 2016-02-10
- Location
- Cortlandt Manor, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLYMEDCO OC LIGHT FOBT TEST (K041297) | Polymedco, Inc. | 2004-08-12 |