FDA (Devices) recall action 82616
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.
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
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.
Becton Dickinson is recalling 124 BD Veritor System Readers due to background calibration issues that may cause false positive or negative test results.
Becton Dickinson & Co. is recalling 32 BD Veritor Plus Analyzers because background calibration issues may cause false positive or negative test results.