Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1141-2018 — BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)

U.S. FDA — Device Enforcement · United States · 2018-03-22 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1141-2018
Date of alert
2018-03-22
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Becton Dickinson & Company
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50382903678421
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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