Class 2 Device Recall MAS CardioImmune XL Cardiac Marker Control;

• Date Initiated by Firm: October 20, 2014
• Date Posted: December 04, 2014
• Recall Status: Terminated on March 30, 2015
• Recall Number: Z-0501-2015
• Recall Event ID: 69670
• 510(K)Number: K061196
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: MAS CardioImmune XL Cardiac Marker Control;; Model: CAI-XL1;; ; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
• Code Information: Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.
• Recalling Firm/ Manufacturer: Microgenics Corporation; 46500 Kato Road; Fremont CA 94538
• For Additional Information Contact: Patrick Lynch; 510-979-5000
• Manufacturer Reason for Recall: MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
• FDA Determined Cause: Nonconforming Material/Component
• Action: ThermoFisher sent an Urgent Medical Device Field Corrections dated October 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Foreign customers were sent letters via overnight mail and e-mail. ACTIONS TO BE TAKEN BY THE CUSTOMER: 1. Determine if you are using or have inventory of MAS Cardiolmmune XL, lot CXL16011. 2. Discontinue use and destroy any remaining inventory of MAS Cardiolmmune XL, lot CXL16011 per your local waste ordinances. 3. Retain a copy of this letter for your laboratory records. 4. If you have forwarded kits of MAS Cardiolmmune XL (lot CXL16011) to another laboratory, please provide a copy of this letter to them. 5. Complete the attached Medical Device Field Correction Response Form and return the form within 5 days to Thermo Fisher Scientific Technical Service as instructed in the form below. 6. Please call technical service at 1-800-232-3342, then press option 2, then option 2 or e-mail mas.controls@thermofisher.com to arrange immediate product replacement. If you are a distributor of the product, please contact your affected customer base, advise them of the situation, and provide them with a copy of this letter. You should insert your contact information, e-mail and fax numbers in the Medical Device Field Correction Response Form and request that they return the form to you. You should fill out the distributor section of the attached Medical Device Field Correction Response Form and return the form within 5 days to Thermo Fisher Scientific Technical Service as instructed in the form. Firm intends to try to get a response twice more by mail or telephone to insure we reach all customers. Affected product remaining at firm is quarantined and will be destroyed.
• Quantity in Commerce: 2135 vials.
• Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
• 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 = JJY and Original Applicant = MICROGENICS CORP.