Events

Recall of Device Recall Simplexa Flu A/B & RSV Direct assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Focus Diagnostics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67213
  • Event Risk Class
    Class 2
  • Event Number
    Z-0846-2014
  • Event Initiated Date
    2014-01-10
  • Event Date Posted
    2014-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125152
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Respiratory virus panel nucleic acid assay system - Product Code OCC
  • Reason
    Focus diagnostics is initiating an urgent safety notice correction for simplexa flu a/b & rsv direct assay (mol2650) because focus diagnostics has received some customer complaints of simplexa flu a/b & rsv lots due to sporadic false positive rsv signals, which may result in a higher rsv false positive rate.
  • Action
    Focus Diagnostics sent an Urgent Safety Notice Correction letter dated January 10, 2014, via email and a hard copy letter by mail. The letter informed customers of the correction, product description with codes, product intended use, issue, risk to health, background, recommendation, actions by customers, and contact information. Customers were instructed to check their inventory for the affected product, if customers detect any positive RSV results, confirm the positive result by an alternate method. Customers were asked to complete the "URGENT: SAFETY NOTICE Acknowledgement and Receipt Form Response Required". Customers with questions were instructed to contact their Technical Services department at 800-838-4548, select option 3. For questions regarding this recall call 714-220-1900.

Device

Device Recall Simplexa Flu A/B & RSV Direct assay
  • Model / Serial
    Model Number   MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .
  • Product Description
    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. || The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Manufacturer Address
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA