FDA (Devices) recall action 79223
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
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 specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead in blood samples when used with certain assays.
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.