BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and Lithium Heparin Green Top Tubes may cause inaccurate lead measurements in blood tests using certain lead assays. Affected tubes have specific catalog numbers and shelf lives.
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 specific BD Vacutainer tube types that can lead to inaccurate lead levels in blood tests when used with certain lead testing methods. This affects laboratory use where precise lead measurements are critical.
These tubes can cause an underestimation of lead in blood samples when used with lead testing methods that employ Anodic Stripping Voltammetry (ASV). This means test results might show lower lead levels than actually present, potentially leading to incorrect health assessments.
Laboratories using BD Vacutainer EDTA Lavender, Tan, Pink, or Green Top Tubes with Magellan Diagnostics LeadCare assays may be affected. The risk is low as the issue only impacts test accuracy, not safety.
Check for catalog numbers 366401, 366450, 366643, 367835, 367841, 367844, 367856, 367861, 367862, 367863, 368021, 368047, 368054, 368661, or 364300 on the tubes. The tubes have specific shelf lives and UDI codes listed in the recall notice.
Identify the catalog number on the tube to confirm if it is affected by this recall.
Reach out to your laboratory supplier for guidance on replacing affected tubes with approved alternatives.
These tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays that employ Anodic Stripping Voltammetry (ASV) methodology.
BD Vacutainer EDTA Lavender, Tan, Pink, and Lithium Heparin Green Top Tubes with catalog numbers 366401, 366450, 366643, 367835, 367841, 367844, 367856, 367861, 367862, 367863, 368021, 368047, 368054, 368661, or 364300.
No, but labs should replace affected tubes with approved alternatives to ensure accurate lead testing results.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1139-2018 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1139-2018 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.
