Z-1141-2018 Class I Terminated
FDA device recall Z-1141-2018 was initiated by Becton Dickinson & Company on Mar 22, 2018 and is designated Class I. Reason for recall: 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… The recall status is terminated (terminated Jul 25, 2022). Affected quantity: 64,784,900.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Mar 22, 2018
- Termination Date
- Jul 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,784,900
Product Description
BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)
Reason for Recall
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.
Distribution Pattern
Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico.
Code Information
All lots. Catalog Number (Shelf Life): 1. 367842 (Requested); 2. 367899 (Requested); 3. 368049 (Requested); 4. 368589 (Requested)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1141-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026