Class 2 Device Recall ABL 700 blood gas analyzer

• Date Initiated by Firm: July 05, 2012
• Date Posted: August 08, 2012
• Recall Status: Terminated on August 20, 2013
• Recall Number: Z-2163-2012
• Recall Event ID: 62503
• 510(K)Number: K002290 K041874 K100777 K110416 K111897 K992859
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
• Code Information: ABL725: 441R0086N008, 441R0292N010, and 441R0520N009U ABL 735: 441R0050N001, 441R0231N0009, 441R0234N0010, 441R0292N0009, 441R0303N010, 441R0340N004, 441R0343N010, and 441R0522N008
• 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: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
• FDA Determined Cause: Software design
• Action: The firm, Radiometer, sent two "Priority Level: Urgent" letters one dated July 9, 2012 and the other dated July 24, 2012 to its affected customers via FedEx with tracking. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the attached Recall Response Fax Form via fax to 800-736-0601. The letter informed the customers that a local service representative will be contacting them shortly to install a software update that will prevent this from occuring (in the event that you utilize HL7 version 2.5 or intend to at some future date.) If you have any questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt. 4.
• Quantity in Commerce: 6854 ABL 7xx units
• Distribution: Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.
• 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 = CHL; 510(K)s with Product Code = CHL; 510(K)s with Product Code = CHL