The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product:
- BD Vacutainer® EDTA Lavender, Tan, and Pink Top Tubes
- BD Vacutainer® Lithium Heparin Green Top Tube
- Product Lot Numbers: All
- Distribution Dates: May 5, 2016 to present
- Manufacturing Dates: March 29, 2016 to present
- Devices Recalled in the U.S.: 982,743,603 nationwide
BD Vacutainer® EDTA Blood Collection Tubes are used to collect blood samples from a vein (venous). The tubes are used to transport and process the blood samples for testing in clinical laboratories.
Reason for Recall
BD is recalling their Vacutainer® EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the rubber tube stopper that interferes with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology. The tubes can continue to be used with other non-ASV blood lead level test technologies such as Graphite furnace atomic absorption spectroscopy (GFAAS) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and other assays (non-lead) which do not use ASV methodology.
ASV is the methodology used in Magellan Diagnostics' LeadCare Testing Systems. The tube stoppers contain a substance called thiuram that can sometimes release sulfur-containing gases, which may dissolve into the blood sample and bind the lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample and may cause falsely lower test results. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.
Who May be Affected
- Patients being tested with assays using ASV methodology (i.e. Magellan LeadCare Diagnostics' Testing Systems) whose blood is drawn in the affected BD blood collection tubes.
- Laboratory personnel who perform clinical testing using patient samples drawn in the affected BD blood collection tubes and running assays using ASV methodology (i.e. Magellan Diagnostics' LeadCare Testing Systems).
- Health care providers who interpret these clinical test results.
What to Do
On March 22, 2018, BD posted an Urgent Medical Device Correction Notice on their webpage and BD intends to send the correction notice to all affected customers and distributors starting week of March 26, 2018. Continue to follow FDA's safety communication for testing lead levels, which currently recommends that no venous blood should be tested with Magellan's LeadCare test systems (regardless of the collection tube used).
- Determine the need to evaluate tests performed in your facility for the potential of thiuram interference.
- At FDA's request, BD conducted testing to determine whether clinical laboratory tests other than the Magellan lead tests are affected by this interference. Based on the results of BD's study, the FDA has no reason to believe other tests are impacted by this issue. BD provided additional data for tubes with thiuram versus tubes without thiuram. See the full list of Chemistry and Immunoassays Tests below.
- In addition, BD continues to investigate the potential of thiuram interference with additional tests used in clinical laboratories. Additional tests include metals, cardiac markers, cancer markers, therapeutic drug monitoring tests, and toxicology tests. However, laboratories should determine the need to evaluate their tests for the potential of thiuram interference if a test is not included in the list.
- Share the notification with other relevant personnel.
- Complete the Customer Response Form and return to the BD contact noted on the form to acknowledge receipt of the notification.
Customers or distributors with questions may contact BD at 1-888-237-2762 (select Option #3 and then Option #4) between 8AM and 5 PM CT Monday through Friday.
Date Recall Initiated
March 22, 2018
- BD Customer Letter
- BD Press Release
- FDA Statement
- Safety Issue on Magellan Diagnostics LeadCare Testing Systems
- FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems with Blood Obtained from a Vein: FDA Safety Communication
- LeadCare Plus and Ultra Testing Systems Recall Notice
- LeadCare and the LeadCare II Testing System Recall Notice
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
|Alanine aminotransferase (ALT)||Cholesterol||Gamma glutamyltransferase (GGT)||Progesterone|
|Alkaline phosphatase||Creatine kinase (CK)||High density lipoprotein (HDL)||Testosterone|
|Amylase||Creatine kinase-MB isoenzyme (CK-MB)||Iron||Total bilirubin (TBIL)|
|Aspartate aminotransferase (AST)||Creatinine||Lactate dehydrogenase (LDH)||Total prostate specific antigen (PSA)|
|Beta-human chorionic gonadotropin (β-HCG)||Direct bilirubin (DBIL)||Lipase||Total protein|
|Blood urea nitrogen (BUN)||Ferritin||Low density lipoprotein (LDL)||Total thyroxine (T4)|
|Calcium||Folate||Magnesium||Total triiodothyronine (T3)|
|Carbon dioxide||Follicle stimulating hormone (FSH)||Phosphorous||Triglycerides|
|Chloride||Free triiodothyronine (T3)||Potassium||Uric acid|
|Thyroid stimulating hormone (TSH)||Free thyroxine (T4)||Troponin||Vitamin B12|
Hematology and Immunology tests
|Complement C3||Complete blood count with differential|
|Immunoglobulin A (IgA)|
|Immunoglobulin G (IgG)|
|Immunoglobulin M (IgM)|