Events

Recall of Calcium Arsenazo, CALA0250

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SEPPIM SAS.

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
    66331
  • Event Risk Class
    Class 2
  • Event Number
    Z-0178-2014
  • Event Initiated Date
    2013-09-04
  • Event Date Posted
    2013-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122064
  • 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
    Azo dye, calcium - Product Code CJY
  • Reason
    Calcium arsenazo reagent, reference cala-0250, is recalled due to complaint of plasma specimens report high results than serum.
  • Action
    ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: " Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample. " ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be removed from the documentation. If you have inventory of CALCIUM ARSENAZO, reference CALA- 0250. All lots. in your laboratory, please discard the insert that you have and replace it with the insert enclosed with this notice. " If you have transferred any of this product to another location, please forward a copy this bulletin to that location. " All users receive CALCIUM ARSENAZO, CALA-0250, from distributors. To be certain everyone who is possibly affected by this change is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached receipt confirmation to Technical Support by fax (401-642-9003) within 48 hours of receipt. We apologize for the inconvenience that this situation can cause in your laboratories; we remain at your disposal for further information. If you have any questions, please contact Technical Support at 1-855-ELITECH (855-354-324) We thank you for your cooperation and the attention which you will give to this bulletin.

Device

Calcium Arsenazo, CALA0250
  • Model / Serial
    Lot numbers distributed in the US:  Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014.  Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of KY and UT and the country of Sweden.
  • Product Description
    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. || The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. || The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . || CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
  • Manufacturer
    SEPPIM SAS

Manufacturer

SEPPIM SAS
  • Manufacturer Address
    SEPPIM SAS, ZONE INDUSTRIELLE, SEES France
  • Source
    USFDA