viernes, 23 de marzo de 2018

FDA MedWatch - BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests

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BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests

BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes
BD Vacutainer Lithium Heparin Green Top Tube
AUDIENCE: Risk Manager, Nursing, Laboratory
ISSUE: 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. 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.
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.
BACKGROUND: 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.
RECOMMENDATION: On March 22, 2017, BD sent an Urgent Medical Device Correction Notice to all affected customers and distributors. The notice asked them to:
  • 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 in the Recall Notice.
    • 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the recall notice, at:

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