The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations.
The warning letter, which follows an inspection of the North Billerica, MA, site last May and June, notes that Magellan made a "significant change by adding to the device labeling an instruction that users allow the blood-treatment reagent mixture to stand for 4 hours at room temperature prior to analysis for venous blood samples that are shipped or rocked."
But FDA says, "This change could significantly affect the safety or effectiveness of the device and requires submission of a new 510(k). Your firm did not notify FDA of this significant change before introducing the modified LeadCare II System into commercial distribution, and FDA has not received a new 510(k) for the device to date."
During the inspection, FDA also noted that the company’s Director of Quality Assurance and Regulatory Affairs explained that the firm had been unable to determine how to convert a customer support request into a customer complaint, raising questions about the company’s ability to track events that have to be reported as medical device reports.
In July, FDA said Magellan may have violated federal law in its handling of customer complaints.
FDA also raises questions with the firm because it has "not provided supporting documentation for your firm’s corrective actions, including documentation to support that you have performed adequate validations."
In May, FDA also warned that all four of Magellan Diagnostics' LeadCare testing systems may provide inaccurate results when testing blood drawn from a patient's vein. However, the agency says it does not have reason to believe the tests are inaccurate when done with capillary blood taken from a patients' finger or heel.
Meridian Bioscience said in a statement that they are committed "to strengthening Magellan’s quality system and ensuring all aspects of the system are in full compliance. Both organizations take this very seriously. Magellan is addressing the observations noted in the Form FDA 483 and the Warning Letter with the highest sense of urgency."
Magellan Diagnostics, Inc. 10/23/17
Editor's note: Article updated on 10/24/17 with Meridian comment.