Recall notificaton - BD EDTA tubes (lavender, tan & pink tops) and lithium heparin tubes (green top) instructions for use update

Mar 18, 2018


BD has recently determined that the curing agent thiuram, used in the processing of rubber stoppers since 1996, can lead to release of carbon disulfide (CS2) and carbonyl sulfide (COS) gases into the headspace of the tubes. These gases can dissolve into the blood sample to chelate lead, and therefore interfere with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology. Although the thiuram has been used since at least 1996, the release of CS2 and COS gases into the headspace and their effect on ASV methodology was only recently observed. ASV is the methodology used in Magellan Diagnostics’ LeadCare® Testing Systems. 

BD has conducted studies using BD Vacutainer® EDTA tubes to evaluate the potential interference of thiuram on lead tests results.  BD has also evaluated the impact of thiuram interference on tests for commonly used analytes, a variety of molecular structures and classes of analytes, and a variety of test instruments/methodologies (please see below for further information on the analytes tested).

Laboratories should follow FDA’s May 17, 2017 safety communication 1 for testing lead levels, which recommends that no venous blood should be tested with Magellan’s LeadCare test systems (regardless of the collection tube used).

On May 17, 2017, FDA issued a Safety Communication recommending laboratories and health care professionals discontinue use of Magellan Diagnostics Inc.’s (Magellan Diagnostics) LeadCare® Testing Systems with venous blood samples due to potential for suppression (underestimation) of lead levels in the blood specimen, potentially causing inaccurate diagnostic results. 1 Based on BD’s extensive investigation, BD has added the following precaution for BD Vacutainer ® Lavender, Tan, and Pink Top tubes and BD Vacutainer® Lithium Heparin Green Top tubes to its IFU. At this time, FDA recommends that no venous blood (regardless of the collection tube) should be used with the Magellan LeadCare test systems.

“Precaution: BD Vacutainer® EDTA tubes (Lavender, Tan, and Pink Top tubes) and BD Vacutainer® Lithium Heparin Green Top tubes are not recommended for use with Magellan Diagnostics LeadCare® assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.”

If you require further assistance, please contact BD at 1-888-237-2762 (select Option #3 and then Option #4) between 8AM and 5 PM CT Monday through Friday.

Resources

Files available for download


References
  1. FDA Safety Communication dated May 17, 2017: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm558733.htm

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