Events

Recall of Device Recall Simplexa Flu A/B and; 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
    67436
  • Event Risk Class
    Class 2
  • Event Number
    Z-1144-2014
  • Event Initiated Date
    2014-02-04
  • Event Date Posted
    2014-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125449
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Respiratory virus panel nucleic acid assay system - Product Code OOC
  • Reason
    Focus diagnostics initiated the recall of the certain simplexa flu alb & rsv direct assay kits due to the potential of false positive flu a, flu b and rsv signals.
  • Action
    Focus Diagnostic initiated this recall on February 4, 2014 by sending recall notification letters to customers via email. The letter dated February 4, 2014, titled "URGENT: SAFETY NOTICE REMOVAL", informed customers of the recall (removal). The letter provided the following information: product description with code, reason for recall, the issue, the risk to health, recommendation, background, actions by customers, contact information, labeling, and response sheet.

Device

Device Recall Simplexa Flu A/B and; RSV Direct assay
  • Model / Serial
    Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
  • Product Description
    Simplexa Flu AlB & RSV Direct Assay Kits, 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. Model Number MOL2650.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

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