Reported Apr 10, 2013 · Terminated
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of…
Polymedco, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymedco, Inc · 510 Furnace Dock Rd · Cortlandt Manor, NY · 10567-6220
Is this the product you have?
- Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M 2 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 3 Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M 4 Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M 5 Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M 6 Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M. - Amount recalled
- 229,600 test strips
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Polymedco, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.