Events

Recall of Device Recall Diametrics Medical IRMA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diametrics Medical, 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
    26714
  • Event Risk Class
    Class 3
  • Event Number
    Z-1072-03
  • Event Initiated Date
    2003-07-14
  • Event Date Posted
    2003-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28243
  • 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
    An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
  • Action
    The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.

Device

Device Recall Diametrics Medical IRMA
  • Model / Serial
    The lot on the boxes of the product is ALHCB (this is the correct lot) and is incorrectly printed as ALOHC on the packages of the recalled disposable cartridges.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
  • Product Description
    IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).
  • Manufacturer
    Diametrics Medical, Inc.

Manufacturer

Diametrics Medical, Inc.
  • Manufacturer Address
    Diametrics Medical, Inc., 2658 Patton Road, Roseville MN 55113
  • Source
    USFDA