Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters 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), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

Radiometer sent a Product Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following steps immediately: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 on already installed Crea membrane units to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Until further notice the following must be carried out every 24 hours: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Please do not report Crea results unless the membrane unit has been verified as described above. If you already run S7835 AutoCheck 6+ level 1, every 24 hours, as part of your regular QC schedule, you do not need to do anything additional. Please review your QC results to ensure the results are within the QC range. Please complete and return the attached fax form, with your signature as soon as possible or within 7 days. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900, ext 209.