Test Strips packaged in the OC-Light Manual iFOBT Kit — Class II medical device recall Z-1059-2013
Terminated recall by Polymedco, Inc, reported 2013-04-10, distributed nationwide. The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being r
| Recall number | Z-1059-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymedco, Inc, Cortlandt Manor, NY, United States |
| Recall initiated | 2013-02-12 |
| Classified | 2013-04-04 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2016-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 355,350 test |
| Reason classes | labeling |
| Lot numbers | 18004M, 19006M, 1X009M, 1X010M, 1Y012M, 25011M, 26012M, 26013M, P205877, P210125, P210194, P210204, P212420, P212421, P217043, P234499, P234664, P238025, P238028, P243938 |
| Model numbers | FOB50 |
| Expiration dates | 2013-02-28, 2013-03-31, 2013-04-30, 2013-05-31, 2013-11-30, 2013-12-31 |
Product
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1059-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.