Recall Z-1293-2015 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Radiometer America Inc
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
| Date | Mar 18, 2015 (initiated Oct 29, 2014) |
| Status | Terminated |
| Reason | Negative drift on QC during in-use lifetime of CREA membranes can be observed. |
| Root cause | Under Investigation by firm |
| Action | 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 me |
| Quantity | 10,824 boxes |
| Distribution | Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy, India, Sweden, Germany, Australia, Hungary, Great Britain, Norway, Uruguay, France, Poland, Switerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051968 | ABL8X7 FLEX Radiometer Medical Aps, Oct 16, 2006 |