viernes, 23 de marzo de 2018

Recalls, Market Withdrawals, & Safety Alerts > BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes

Recalls, Market Withdrawals, & Safety Alerts > BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes





BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes


BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it is updating the instructions for use of certain BD Vacutainer® tubes as part of its quality process to ensure that customers understand the appropriate uses of these products.
Since BD became aware of the concerns about inaccurate lead test results from Magellan Diagnostics LeadCare® Testing Systems, the company has been cooperating fully with the U.S. Food and Drug Administration (FDA). BD launched an internal investigation and determined that Anodic Stripping Voltammetry (ASV) technology, which is used in Magellan LeadCare testing systems, is not compatible with thiuram, a material found in the rubber stoppers of the BD Vacutainer® EDTA Lavender, Pink and Tan top tubes and BD Vacutainer® Lithium Heparin Green top tubes. Thiuram has been in these rubber stoppers since 1996, however, the effect of thiuram on lead testing when used with ASV technology was only recently observed through the course of this investigation. 

No hay comentarios: