State told physicians to stop using Magellan Diagnostics lead-testing devices in 2017 and ′21

Former executives at North Billerica company were charged in federal court Wednesday

Reba Daoust (center), one of the former executives, was released on personal recognizance.Suzanne Kreiter/Globe Staff

The problems at Magellan Diagnostics in Billerica first became public in 2017 when the Food and Drug Administration warned that the company, self-marketed as “the most trusted name in lead testing,” was having serious issues with some of its devices returning false results.

Six years later, the scope of the problem with the lead tests resurfaced this week with the arrest of three former Magellan executives on wire fraud and other charges for allegedly hiding the issue from regulators and knowingly selling defective machines.

On Thursday, pediatrician Dr. Mary Beth Miotto recounted how Massachusetts officials conducted two rounds of aggressive outreach, beginning in 2017, to notify physicians since the problems with Magellan’s devices first surfaced. And that may mean that any children who received false negative results have already been retested.

In 2017, doctors using the Magellan machines were urged to contact families to have their children retested. Another round of warnings from the state came after the devices were recalled in 2021, when staff members at the Department of Public Health called every health care provider in the state using Magellan devices and confirmed they had stopped doing so, according to the department.

“Each time there has been anything that might put any child at risk of escaping attention for possible lead poisoning, the state health department has been really proactive,” said Miotto, president of the Massachusetts Chapter of the American Academy of Pediatrics.

The state agency, which runs the state’s Childhood Lead Poisoning Prevention Program, declined to answer questions but provided a written statement with some background on the Magellan lead tests. The 2021 recall involved 30 percent of all annual lead testing for Massachusetts children.

The state requires lead screening for children at age 1, 2, and 3, and at age 4 in high-risk communities. Young children are at highest risk because they absorb lead more easily and because the blood-brain barrier is not yet intact, said Dr. Noah Buncher, who heads the Lead Clinic at Boston Medical Center. There is no safe level of lead in the body, and if present in a young child’s blood, it can cause irreparable harm, affecting learning and development, and potentially leading to behavioral problems.

A false negative, Buncher said, means “there are kids who are being exposed and poisoned who we’re not catching.”

“If we’re missing children, we’re allowing them to continue to exist in these lead-hazardous homes, and continue to be exposed to lead, which leads to more damage or health consequences. The biggest piece of lead treatment is avoiding ongoing exposure.”

Most medical devices undergo a far less stringent review by the Food and Drug Administration than medicines.

All four of Magellan’s lead-testing systems — LeadCare, LeadCare II, LeadCare Ultra, and LeadCare Plus — were approved under a streamlined FDA review that enables device makers to save time and money by showing their products are “substantially equivalent” to others already on the market.

The faster approval process, which has become common for devices seen as having lower risk, can take as little as 16 months, compared to more than three years for devices deemed higher risk.

It’s not clear whether the faster process contributed to the malfunctioning machines. FDA officials did not immediately respond to questions about its review of the Magellan machines.

The problems at Magellan Diagnostics trace back to a test in 2013, and an undesired result.

Magellan was running the test on its newest product in a line of machines designed to identify lead levels in a child or a pregnant woman, according to the indictment of the three former executives.

The results indicated a “malfunction” with the device, called LeadClear Ultra, as it “tended to lower blood lead values” in samples that had just been mixed with a treatment reagent, and higher levels of lead when the mixture was left to sit, federal prosecutors said in a 46-page indictment against the three former Magellan executives that was unsealed this week.

“I hope this turns out to be nothing,” Reba Daoust, then director of quality assurance and regulatory affairs, wrote on the day following the test, according to prosecutors.

In the indictment, prosecutors allege Daoust, former chief executive Amy Winslow, and former chief operating officer Hossein Maleknia were all aware of the potential for false readings and hid that information from the public and the FDA for the next four years, misleading the families of millions of children and pregnant women.

Moreover, the three are accused of taking steps to avoid disclosing information about the malfunction even when it was discovered in its biggest money earner, LeadClear II.

The allegations drew a rebuke from Senator Edward Markey, who in 2017 cosigned a letter calling for a federal probe of Magellan after the issues with false-negative results surfaced.

“There is no safe level of lead in the blood, and there should be no safe haven for companies like Magellan Diagnostics that endanger our young people,” Markey said in a statement Thursday.

The investigation into Magellan is ongoing, and the FBI is asking anyone who believes they received an inaccurate result from a LeadCare device to share their information in a short online form.

When a hospital in Baltimore and a testing laboratory raised questions in August 2014 about inaccuracies in their test results, Magellan allegedly fabricated an answer that failed to disclose a “malfunction” had been discovered before the product hit the market, prosecutors allege.

In 2016, Magellan Diagnostics was sold to Cincinnati-based Meridian Bioscience for $66 million. Winslow was kept on as chief executive of Magellan following the acquisition and received a $2 million bonus, while Maleknia collected $448,000, authorities allege.

In May 2017, the FDA issued a press release warning consumers not to use any Magellan tests with blood drawn from the vein and encouraged children under 6 and pregnant or nursing women to consult their physician about getting a new test.

That year, 2.5 million children — half of all children tested in the United States — were tested using the LeadClear II machine, prosecutors said.

The day of the FDA’s press release, Meridian stock fell by more than 8 percent, according to a class-action lawsuit filed by Meridian shareholders in November 2017, which alleged the company “engaged in a scheme to deceive the market” and inflate its stock price. The lawsuit ended in a settlement.

On Wednesday, Meridian said it is cooperating with federal authorities in the investigation against the three former Magellan executives and noted that “Meridian and its subsidiaries are not defendants in the action.”

Winslow and Daoust appeared in US District Court in Boston on Wednesday, where they pleaded not guilty and were released on personal recognizance. Maleknia, who lives in Florida, was released on personal recognizance and ordered to connect with officials in Boston, according to records.

Winslow’s attorney, William Trach, on Wednesday said his client “did not commit any crimes” and faulted federal prosecutors for bringing the charges. According to her LinkedIn profile, Winslow was chief executive of Magellan from 2011 to 2018. She is now president of NanoImaging Services, according to her LinkedIn profile.

Robert Weisman of the Globe staff contributed to this report.