FDA Alerts

Class 1 Recall: Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication

Sciex notified the FDA that, under certain conditions, the defect in the software versions identified above may lead the devices to display results that do not match the specimens tested.

Thu Sep 01 2016By Jonathan Payne

Class 1 Recall: Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication

 

September 1, 2016
 
Audiences:
  • Laboratory professionals and State Health Laboratories who use Sciex (previously known as AB Sciex) mass spectrometers
  • Health care professionals who rely on test results provided by Sciex mass spectrometers
 
Medical Specialties:
All specialties may be impacted but tests using mass spectrometers may be particularly common for Anesthesiology, Neurology, Pain Management, Medical Genetics, Obstetrics and Gynecology, Prenatal Testing, Clinical Pathology, Infectious Disease, Psychiatry, Emergency Medicine, and Internal Medicine/Pediatrics.
 
Product:
The Sciex API 3200TM LC/MS/MS System, 3200MD QTRAP® LC/MS/MS System, Triple QuadTM 4500 LC/MS/MS System, and the QTRAP® 4500 LC/MS/MS equipped with:
  • the Analyst Software Versions 1.6.1 and 1.6.2, and
  • the MultiQuant Software Versions 3.0, 3.0.1, and 3.0.2.
Mass spectrometers are devices used in lab settings to identify inorganic or organic compounds (e.g. lead, mercury, drugs, proteins, and peptides) in human specimens. The devices separate isotopes, molecules, and molecular fragments according to their mass through electric and magnetic fields. Health care professionals may use the results to aid in their clinical diagnosis or to help evaluate possible treatment decisions.
 
Purpose:
The FDA is alerting lab staff and health care professionals about a software defect in Sciex mass spectrometers. This software defect may cause the devices to incorrectly assign results to samples analyzed.
 
Summary of Problem and Scope:
Sciex notified the FDA that, under certain conditions, the defect in the software versions identified above may lead the devices to display results that do not match the specimens tested. This is of concern because health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices. A potential inaccurate clinical diagnosis or treatment decision may lead patients to experience serious adverse health consequences.
 
The mass spectrometers manufactured by Sciex are medical devices specified either for clinical diagnostic use or for research use only (RUO). RUO devices are typically in a development stage and must be labeled "For Research Use Only. Not for use in diagnostic procedures."
 
The company has sent Urgent Medical Device Correction Letters and issued two voluntary recalls for the mass spectrometers for clinical use. However, there may be customers of the RUO version of the mass spectrometers that are using them for clinical purposes. Since Sciex has not notified its customers of the RUO version about the issues associated with the software defect in the instruments, we are concerned that these customers, which include clinical laboratories, may be unaware of the issue and its potential impact on results generated by the device.
 
Tests that use the RUO version of these devices for clinical decision making, such as Laboratory Developed Tests (LDTs) 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.
 
Recommendations for Laboratories and Health Care Facilities
The FDA recommends the following:
  • Determine if your facility owns and uses one of the mass spectrometers equipped with the software listed above;
  • Contact Sciexdisclaimer icon for necessary software corrections; and
  • If necessary, laboratories should follow CLIA requirements to investigate and take appropriate corrective action when errors have been known, or are suspected to have occurred.
 
FDA Actions:
Since March 2016, the FDA has been working with Sciex to address the concerns of the mass spectrometers listed above. The FDA will continue monitoring the situation and working with the company to assure the safety and effectiveness of these devices, and will keep the public informed if significant new information becomes available.
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