Class 3 Device Recall VITROS CKMB Calibrators

• Date Initiated by Firm: April 03, 2013
• Date Posted: May 17, 2013
• Recall Status: Terminated on March 02, 2017
• Recall Number: Z-1337-2013
• Recall Event ID: 64901
• 510(K)Number: K973030
• Product Classification: Calibrator, multi-analyte mixture - Product Code JIX
• Product: VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK ; ; For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).
• Code Information: Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Ms. Jennifer Paine ; 908-218-8776
• Manufacturer Reason for Recall: Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.
• FDA Determined Cause: Process control
• Action: Ortho Clinical Diagnostic sent a " Important Product Correction Notification" letter dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed of the issue and advised they must discontinue storage of opened-reconstituted vials of VITROS CK-MB Calibrators frozen at -20 degrees Celsius (-4 degrees Farenheit). The same day, the Distributor letters were sent via US Postal Service Priority Mail or FedEx overnight courier to US Distributor consignees who were informed of the issue and instructed to notify their customers of the issue and actions. Also on April 3, 2013, the foreign affiliates were informed of the issue by e-mail and instructed to notify their consignees of the issue and actions. Confirmation of Receipt - Important Response Required so that we can complete our records, please return this form to us no later than April 19, 2013. FAX: 1-888-557-3759 or 1-585-453-4110 We apologize for any inconvenience this may have caused your laboratory. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.
• Quantity in Commerce: Domestic: 3019 units, Foreign: 905 units
• Distribution: Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
• 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 = JIX and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.