FDA (Devices) recall action 79769
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 package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
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 BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.
Becton Dickinson is recalling BD MAX DNA MMK Lab Use because the package insert incorrectly lists the diluent volume, which could affect assay results.