An agency inspection of Siemens’ New York manufacturing facility found multiple quality control issues related to the products, including problems with the design review and missing documentation.
The FDA claimed that Siemens altered the Centaur system without following proper protocol to file the changes with the federal watchdog agency, and that the facility lacked procedures for handling complaints and vetting them for potential investigation.
The agency further alleged that Siemens failed "to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient."
The Centaur immunoassay system won FDA 510(k) clearance in Sept. 2009, but did not conduct a validation report on changes made to the system, according to the warning letter.
"The effect of the device changes on performance was not documented until these reports were completed, but your firm’s assessment claimed that there was no change in performance requiring a pre-market submission," according to the inspector.
Siemens has had a mixed bag of legal and regulatory news recently.
Early last month the company revealed a new investigation into payments made to employees at a Russian facility and a U.S. probe into the company’s diagnostics business.