Recall Z-1060-2013— Polymedco, Inc
Class II · Terminated
Class II FDA medical device recall by Polymedco, Inc, initiated 2013-02-12, terminated 2016-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.. 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..
- Recalling firm
- Polymedco, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-12
- Terminated
- 2016-02-10
- Firm location
- Cortlandt Manor, NY, United States
Product description
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.