FDA (Devices) recall action 64537
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.
Polymedco is recalling OC-Light iFOBT test strips because they may not be stable through their labeled shelf-life, potentially causing false negative results.