Recall Z-1059-2013— Polymedco, Inc

Name: FDA recall Z-1059-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-12

Class II · Terminated

Class II FDA medical device recall by Polymedco, Inc, initiated 2013-02-12, terminated 2016-02-10. It names one FDA 510(k) clearance: K041297. 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: 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

510(k) clearances named in this recall

1 on FDA's record

K041297 — POLYMEDCO OC LIGHT FOBT TESTPolymedco, Inc.·cleared 2004-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.