Class 2 Device Recall ABL90 FLEX

• Date Initiated by Firm: January 12, 2011
• Date Posted: April 28, 2011
• Recall Status: Terminated on May 09, 2012
• Recall Number: Z-2112-2011
• Recall Event ID: 58273
• 510(K)Number: K092686
• Product Classification: Electrode, ion specific, potassium - Product Code CEM
• Product: ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. ; ; The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
• Code Information: Part Number: 393-090, all production runs for Serial Numbers: 393-090R0026N0010 to 393-090R0082N0005.
• 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: Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the
• FDA Determined Cause: Software design
• Action: The firm, Radiometer America, sent two Urgent "Medical Device Field Correction" letters issued on February 4, and on February 24th, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to replace the sensor cassette. In order to prevent this situation from occurring, the firm informed the customers in the recall/correction notification that they intend to upgrade all ABL 90 Flex analyzers to a new software version. The new software will perform a check during a normal system FLUSH in order to allow the analyzer to detect the bias and will notify the customer immediately of this condition and will automatically disable the cassette thus preventing further use. The letter goes on to remind the device customers that until such time as the software upgrade is installed, they should make sure to adhere to the procedures stated in the Reference Manual which call for the replacement of the sensor cassette immediately upon receiving message #1310. The letter further instructs the customer to complete and return the attached FAX RETURN FORM via fax to 440-871-0463. The letter also states that the expected release date for the new software should be sometime in the second half of February 2011. If you have any questions regarding this letter, or the upgrade, please contact Technical Support staff at 1-800-736-0600 Opt 4.
• Quantity in Commerce: 32 units were distributed in the U. S. and 533 units were distributed world-wide
• Distribution: Worldwide distribution: USA including states of CA, DC, PA, MN, NY, NJ, TX, OH, MO, WI, UT, and MI; and country of Canada.
• 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 = CEM and Original Applicant = RADIOMETER MEDICAL APS