Becton Dickinson recalls EDTA Tan Top Tubes for potential lead underestimation in blood tests using ASV methodology. Affected tubes have catalog number 367855 (UDI: 50382903678551).
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.
Becton Dickinson is recalling EDTA Tan Top Blood Collection Tubes because they can cause inaccurate lead measurements in blood tests using certain methods. This affects lab tests that use the Anodic Stripping Voltammetry technique. The issue doesn't pose a direct risk to users but could lead to incorrect health assessments.
These tubes can cause blood lead levels to be underestimated when used with specific lead testing methods that employ Anodic Stripping Voltammetry. This means test results might not detect lead exposure properly, potentially missing health risks.
Lab technicians and healthcare providers who use these tubes for blood lead testing with ASV methods are most at risk. Patients receiving blood tests using these tubes may get inaccurate lead results.
Check for BD Vacutainer EDTA Tan Top Tubes with catalog number 367855 (UDI: 50382903678551). All lots of this tube are affected.
Verify the catalog number on the tube label to confirm it's affected.
No, the recall doesn't require immediate stop use. The tubes can be used with caution for lead testing if you follow the lab's procedures.
The official notice doesn't specify a remedy, so contact your lab supplier for guidance on handling affected tubes.
The recall specifically affects EDTA Tan Top Tubes with catalog number 367855. Other tube colors and types are not included.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1140-2018 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1140-2018 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
