Events

Recall of Device Recall QUANTALyser 240 IFA

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

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
    79380
  • Event Risk Class
    Class 2
  • Event Number
    Z-1221-2018
  • Event Initiated Date
    2018-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162171
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
  • Action
    The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381.

Device

Device Recall QUANTALyser 240 IFA
  • Model / Serial
    Serial number 4314
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
  • Product Description
    QUANTA-Lyser 240 IFA, Part #GS0242. || The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Manufacturer Address
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA