The FDA this week expanded its Class I recall of lead poisoning tests from Magellan Diagnostics to include 2 additional testing systems.
The regulatory watchdog said it recalled Magellan’s LeadCare testing systems because they may underestimate blood lead levels and provide inaccurate results with venous blood samples.
“Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning,” the FDA wrote. “The use of affected product may cause serious adverse health consequences.”
The expanded recall now includes the company’s LeadCare, LeadCare II, Ultra and Plus systems. The latest communication from the FDA said the 7 million affected products were manufactured from Sept. 2013 to present day and were distributed between Jan. 2014 and May 2017.
Meridian Bioscience (NSDQ:VIVO), Magellan’s parent company, pointed out in a statement that the FDA’s recall only applies to venous blood samples and that the systems can still be used with capillary blood samples.
“Approximately 10% of Magellan’s revenue and approximately 1% of Meridian’s overall revenue is derived from venous blood draws,” Meridian said. “We continue to work with the FDA and do not expect this occurrence to cause any material adverse effect to Meridian’s financial results. Meridian and Magellan continue to take these matters very seriously and continue to work closely and fully with the FDA and CDC to address the concerns identified with venous samples as quickly as possible.”
The FDA added that it is working with the Center for Disease Control and Prevention to determine why the tests are inaccurate.