The story has been updated following the announcement on Friday that BD is recalling the blood collection tubes. Also, a BD spokesman noted that customers do not need to return any products to the company.
NEW YORK (360Dx) – Becton Dickinson is recalling certain of its blood collection tubes after determining a chemical found in them can lead to inaccurate blood lead test results based on Magellan Diagnostics lead poisoning technology, the US Food and Drug Administration said on Friday.
The company issued a Class I recall of its BD Vacutainer EDTA Lavendar, Pink, and Tan top tubes, and BD Vacutainer Lithium Heparin Green top tubes. Class I recalls cover products that may cause serious health problems or death.
A BD spokesman said that despite the recall, customers do not need to return any products to the company, and the products can continue being used in accordance with updated instructions issued by BD on Thursday in which the company told its customers not to use the tubes with Magellan's Leadcare assays that leverage anodic stripping voltammetry (ASV) technology.
The update came after an investigation prompted by a warning letter from the FDA to BD in January which outlined a number of violations of federal law related to the company's Vacutainer blood collection tubes, including changes it made to the tubes and its failure to investigate complaints about their performance.
The warning followed a series of actions by the FDA and the Centers for Disease Control and Prevention that began almost a year ago when the two agencies recommended retesting for people who were tested with certain Magellan technologies' for lead poisoning. Results from the Magellan tests could be inaccurate, FDA and CDC said at the time.
In a statement on Thursday, BD said that following an internal investigation, it determined that ASV technology, which is used in Magellan's LeadCare testing systems, is not compatible with thiuram, a material found in the stoppers of the BD Vacutainer EDTA Lavendar, Pink, and Tan top tubes, and BD Vacutainer Lithium Heparin Green top tubes.
Thiuram has been in the rubber stoppers since 1996, BD said, but its effect on lead testing when used with ASV technology was observed only as a result of its investigation.
Thiuram can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles, resulting in a chemical reaction that makes it difficult for Magellan's lead tests to detect the correct amount of lead in a sample, said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA, in a separate statement on Thursday.
BD advised against use of the tubes with any company's assay that leverages ASV methodology, although it added that it is not aware of any other instrumentation that uses ASV technology. Other lead testing systems — including graphite furnace atomic absorption spectroscopy and inductively coupled plasma mass spectrometry — are not affected by BD's update, it said.
At FDA's request, BD is continuing its investigation into whether clinical laboratory tests aside from Magellan's lead test could be affected by thiuram chemical interference.
St. Pierre said that thiuram may be used in rubber stoppers by both BD and other blood collection tube manufacturers, and the FDA is following up with blood collection tube manufacturers serving the US market to determine whether they may be affected by the same issue. Further, the agency continues to evaluate other factors that may have led to the inaccurate results with Magellan's lead tests.
He also reiterated FDA's recommendation that Magellan's LeadCare System tests not be used with blood samples taken from the vein, though they can be used with blood samples from a finger or heel stick. The FDA and CDC continue to analyze Magellan's LeadCare System tests, and the St. Pierre repeated the FDA's recommendation that anyone who was tested with the technology to get retested.