Class II — Polymedco, Inc
| Recalling firm | POLYMEDCO, INC. |
|---|---|
| Registered facility | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces. |
| Quantity | 355,350 test strips |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam. |
| Initiated | 2013-02-12 |
| Classified | 2013-04-04 |
| Terminated | 2016-02-10 |
| Recall number | Z-1059-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Polymedco, Inc (Z-1059-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64537/
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