Events

Recall of Device Recall EliA Sample Diluent, Article number, 83102301

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Phadia US 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
    76343
  • Event Risk Class
    Class 2
  • Event Number
    Z-1253-2017
  • Event Initiated Date
    2017-01-30
  • Event Date Posted
    2017-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152965
  • 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
    Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
  • Reason
    Erroneous elia test results related to problems with liquid level detection and diluent pipetting in phadia 250 instruments, and deformed bottles. investigation showed problems with the liquid level detection in diluent bottle batch jjca resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
  • Action
    Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: ¿ Stop using the affected lots of the above mentioned product lots ¿ Please, return or attest to scrapping of any unused product lots to the manufacturer and order replacement products free of charge. ¿ Review your records to determine if you have had instrument problems due to deformed bottles. If you find the instrument error message 3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT Target 2, please collect all log files available and/or contact customer support, who will further assist in assessing possible impact on the test results in scope. ¿ Fill in the Medical Device Recall return response on page 3 and return to the manufacturer by e-mail. If customers have any questions, please contact Phadia US, Inc. at 1-800-346- 4364, option #2.

Device

Device Recall EliA Sample Diluent, Article number, 83102301
  • Model / Serial
    EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
  • Product Description
    EliA Sample Diluent, Article number, 83-1023-01
  • Manufacturer
    Phadia US Inc

Manufacturer

Phadia US Inc
  • Manufacturer Address
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Manufacturer Parent Company (2017)
    Fsii Sweden Holdings I Ab
  • Source
    USFDA