NEW YORK (GenomeWeb) – The US Food and Drug Administration today issued a safety communication regarding a defect in Sciex mass spectrometers that can cause instruments to incorrectly assign results to samples.
The issue affects Sciex API 3200 LC/MS/MS, 3200MD QTRAP LC/MS/MS, Triple Quad 4500 LC/MS/MS, and QTRAP 4500 LC/MS/MS instruments running Analyst software versions 1.6.1 and 1.6.2, and MultiQuant software version 3.0, 3.01, and 3.02. A defect in these software packages can cause the instruments to display results that do not match the samples being analyzed.
The FDA said it has been working with Sciex to address this problem since March, and that the company has sent Urgent Medical Device Correction Letters and issued two voluntary recalls for its clinical instruments. However, the agency noted that some clinicians may be using research-use-only versions of the instruments in clinical tests, and that Sciex has not alerted its RUO instrument customers of the software defects.
"Tests that use the RUO version of these devices for clinical decision making, such as Laboratory Developed Tests that incorporate the RUO version of these devices, may produce inaccurate results that may lead health care providers to make inaccurate diagnoses or treatment decisions," the FDA said.