Events

Recall of Device Recall Advanced Instrument Model 2020 MultiSample Osmometer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Instruments, 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
    58042
  • Event Risk Class
    Class 2
  • Event Number
    Z-2068-2011
  • Event Initiated Date
    2011-01-19
  • Event Date Posted
    2011-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98087
  • 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
    Osmotic Fragility Testing - Product Code GKE
  • Reason
    A poorly soldered power cord may pose a potential electrical shock hazard.
  • Action
    Advanced Instruments Product Service Department contacted each customer on 1/19/11 via an Urgent Product Recall Notice. The letter identified the reason for recall along with the affected products. The letter provided instructions to safely examine the date code of the AC Power Inlet assembly on the affected product. If customers were unable to perform the inspection or had questions concerning the instructions, they were to contact Advanced Instruments Product Service Manager at 781-471-2147 or via email jorges@aicompanies.com. The attached response forms were to be completed and returned as instructed.

Device

Device Recall Advanced Instrument Model 2020 MultiSample Osmometer
  • Model / Serial
    Serial Numbers: 10111986C, 10111987C, 10122019C, 10122020C, 10122021C, 10122022C, 10122029C, 10122030C
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of CA, GA IL, NJ, and MA and country of Belgium.
  • Product Description
    Advanced Instrument Model 2020 Multi-Sample Osmometer || Intended to measure the osmotic pressure of body fluids.
  • Manufacturer
    Advanced Instruments, Inc.

Manufacturer

Advanced Instruments, Inc.
  • Manufacturer Address
    Advanced Instruments, Inc., Two Technology Way, Norwood MA 02062-2633
  • Manufacturer Parent Company (2017)
    Advanced Instruments Inc.
  • Source
    USFDA