Class 2 Device Recall calcium membrane jackets

• Date Initiated by Firm: April 07, 2011
• Date Posted: June 16, 2011
• Recall Status: Terminated on February 19, 2012
• Recall Number: Z-2571-2011
• Recall Event ID: 58657
• 510(K)Number: K043218 K914166 K954612 K962334 K974818 K980130
• Product Classification: Electrode, ion, specific, calcium - Product Code JFP
• Product: Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).
• Code Information: Part Numbers: 942-046, all lot numbers between 319 and 325 942-060, all lot numbers between 159 and 252
• FEI Number: 1523456
• Recalling Firm/ Manufacturer: Radiometer America Inc; 810 Sharon Dr; Westlake OH 44145
• For Additional Information Contact: 440-871-8900 Ext. 209
• Manufacturer Reason for Recall: Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used
• FDA Determined Cause: Pending
• Action: The firm, Radiometer America, sent a "MEDICAL DEVICE FIELD CORRECTION" letter dated April 14, 2011, to all affected customers. The letter describes the product, problem and the actions to be taken. The letter provides the customers with a series of steps to be taken when replacing the Calcium Membrane (Until further notice the above procedure must be carried out when replacing the Calcium membrane). The letter also provides quality control instructions for verifying calcium performance. Additionally, the customer is required to manually adjust the upper and lower QC limits on the analyzer in relation to the limits printed on the insert sheet in order to detect the bias during quality control measurements (This must be done for every lot of QC ampoules used, and for any new lot of ampoules installed). The letter asks that each customer complete and return the attached form via fax to 440-871-0463, in order to verify that the notification letter was received. Questions should be directed to the firm's Technical Support staff at 800-736-0600, Opt. 4.
• Quantity in Commerce: 30323 boxes
• Distribution: Worldwide Distribution--USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, Austrailia, Bahrain, Belarus, Belgium, Brazil, Brunei Darussalam, China, Columbia, Cuba, Greece, Denmark, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greenland, Guatemala, Hungary, India, Iraq, Ireland, Isreal, Italy, Jamaica, Japan, Kasakhstan, Kenya, Lebanon, Lithuania Korea, Malaysia, Malta, mexico, Moldavia, Nepal, New Zealand, Norway, Netherlands, Peru, Philipines, Poland, Portugal, Qatar, Oman, Rumania, Russia, Saudi Arabia, Singapore, Serbia and Kosvo, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Syria, Thailand, The Netherlands, Tunesia, Turkey, UK, Ukraine, United Arabia Emirates, Urguary, Usbekistan, 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 = JFP; 510(K)s with Product Code = JFP