Events

Recall of S1730 Calibration Solution 2, 200 mL, REF 944025.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    35663
  • Event Risk Class
    Class 3
  • Event Number
    Z-1460-06
  • Event Initiated Date
    2005-10-31
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46573
  • 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
    Calibration solution - Product Code CHL
  • Reason
    Calibration solution for abl700 blood gas analyzers is labeled with an incorrect bar code. the bar code identified on the cal solution 2 product is actually the bar code for the rinse solution.
  • Action
    Representatives of the recalling firm were informed of this problem and were asked to visit the firm''s customers and retrieve any of the suspect product found in inventory at each customer location for customer credit. The representatives were instructed to complete this action via a ''Management Cover e-mail issued on 10/31/2005. According to the Management Cover Memo, these actions were scheduled for completion by firm representatives on or before 12/15/2005.

Device

S1730 Calibration Solution 2, 200 mL, REF 944025.
  • Model / Serial
    Part #944-025, Lot QR-02, Expiration Date: September 2007.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled product was distributed to customers in following states nationwide: AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV and WY
  • Product Description
    S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA