The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning BD Vacutainer EDTA tubes and BD Vacutainer Lithium Heparin Green Top Tubes, manufactured by Becton Dickson and company (BD). The affected products are listed below:
Based on data provided by BD (the manufacturer), the FDA has concluded that one of the contributing factors to the inaccurate LeadCare test results is the chemical composition of the rubber stoppers of certain blood collection tubes.
The FDA requested the manufacturer to conduct studies to assess the accuracy of Magellan's LeadCare testing systems when used with venous blood collected into BD venous blood tubes. The FDA concluded that the studies performed by the manufacturer were robust and showed that there was a significant chance of incorrect results with Magellan's LeadCare tests when used with venous whole blood collected in certain BD blood tubes.
Upon further investigation, the manufacturer determined that the affected tubes' rubber stoppers contain a chemical called thiuram that can release reactive gases, carbon disulfide (CS2) and carbonyl sulfide (COS), which can dissolve into the blood sample and bind tightly to lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample.
The FDA also requests the manufacturer to conduct testing to determine whether clinical laboratory tests other than the Magellan lead tests are affected by the thiuram chemical interference. Based on the results of the studies to date and the understanding of the mechanism of the interference, the FDA does not believe there is evidence showing that other clinical laboratory test results are impacted by the thiuram chemical interference at this time. The manufacturer is notifying their customers about this information.
According to the FDA Thiuram may be used by manufacturers other than BD to manufacture rubber stoppers for blood collection. The FDA is following up with manufacturers of blood tubes marketed in the U.S. to investigate this issue. The FDA continues to recommend that venous samples not be used with Magellan lead tests. This recommendation applies to all venous blood collection tubes. Capillary blood may continue to be tested with the Magellan lead tests.
For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LabTest/ucm566188.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 March 2018