Events

Recall of Clinical Chemistry Iron/Magnesium Calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories 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
    48172
  • Event Risk Class
    Class 2
  • Event Number
    Z-0950-2009
  • Event Initiated Date
    2008-04-24
  • Event Date Posted
    2009-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70929
  • 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
    Multi-Analyte Mixture Calibrator - Product Code JIX
  • Reason
    An incorrect magnesium calibrator 2 value (cal 2) was provided for clinical chemistry iron/magnesium calibrator lot number 54187m200. use of the incorrect magnesium cal 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8meq/l (1.0 mg/dl or 0.4 mmol/l).
  • Action
    On April 24, 2008, a Product Correction letter with attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. Customer reply form were included in all US customers letter. The letter instructed customers to: 1. Identify the lot number of Clinical Chemistry Iron/Magnesium Calibrator currently used in your laboratory 2. If you have lot number 54187M200, cross out the incorrect Magnesium CAL 2 value in the value sheet, commodity 30-3535/R1, June 2005. Place a copy of this letter in all calibrator kits with this lot number. 3. Enter the revised Magnesium CAL 2 value provided in this letter in your system. NOTE: Ensure that the value used corresponds to the units of concentration used in your laboratory. *ARCHITECT cSystems - Refer to Enter a calibrator concentration (cSystem) in Section 2, Installation procedures and special requirements of the ARCHITECT System Operations Manual. *AEROSET - Refer to Calibrator/Control Configuration in Section 2, Installation Procedures and Special Requirements of the AEROSET System Operations Manual. 4. Calibrate the Magnesium assay. Verify the calibration with at least two levels of controls according to the established quality control requirement for your laboratory. Customers were also instructed to please retain this communication for future reference and if they have forwarded any Clinical Chemistry Iron/Magnesium Calibrator to another laboratory, please provide a copy of this letter to them. An 800 number was provided in the recall letter for any questions the affected customers or any of the health care providers they serve may have.

Device

Clinical Chemistry Iron/Magnesium Calibrator
  • Model / Serial
    Lot Number: 54187M200
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, and WI, and countries of Mexico, Chile, Puerto Rico, Canada, Thailand, Curacao, Guatemala, Argentina, Dominican Republic, Germany, New Zealand, Jamaica, Ecuador, Brazil, El Salvador, Hong Kong, and Bermuda.
  • Product Description
    Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200 || For use in the calibration of the Iron and Magnesium assays.
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • Manufacturer Address
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA