Class 2 Device Recall Crea Calibration solution

• Date Initiated by Firm: December 16, 2011
• Date Posted: February 13, 2012
• Recall Status: Terminated on January 17, 2014
• Recall Number: Z-1008-2012
• Recall Event ID: 60929
• 510(K)Number: K051968
• Product Classification: Electrode, ion based, enzymatic, creatinine - Product Code CGL
• Product: S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
• Code Information: S1827 Part Number: 944-135, lot DV02
• Recalling Firm/ Manufacturer: Radiometer America Inc; 810 Sharon Dr; Westlake OH 44145-1521
• For Additional Information Contact: 440-871-8900 Ext. 209
• Manufacturer Reason for Recall: When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.
• FDA Determined Cause: Device Design
• Action: Radiometer sent a Medical Device Recall letter dated December 28, 2011 to their customers. The letter provided details on the affected devices, description of the problem and actions to be taken. The firm instructed their customers to immediately examine their stock and return any remaining product to Raiometer America Inc. for disposal. The letter states that Radiometer will replace all bottles of the affected lots, at no charge. Customers were asked to complete the attached Recall Response Fax Form and fax to 800-736-0601. For questions regarding the Recall contact Radiometer America Technical support at 1-800-736-0600 opt. 4.
• Quantity in Commerce: 7 boxes/6/175mL bottles
• Distribution: Nationwide Distribution (USA) including the states of: NY, PA and TN.
• 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 = CGL