Class 2 Device Recall Calcium Arsenazo, CALA0250

• Date Initiated by Firm: September 04, 2013
• Date Posted: November 07, 2013
• Recall Status: Terminated on December 12, 2013
• Recall Number: Z-0178-2014
• Recall Event ID: 66331
• 510(K)Number: K110830
• Product Classification: Azo dye, calcium - Product Code CJY
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: SEPPIM SAS; ZONE INDUSTRIELLE; SEES France
• For Additional Information Contact: 855-354-8324
• Manufacturer Reason for Recall: Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 47 kits in US and 48 kits in Sweden
• Distribution: Worldwide Distribution - US including the states of KY and UT and the country of Sweden.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CJY