Recall Z-1046-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Radiometer America Inc
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
| Date | Feb 9, 2015 (initiated Dec 8, 2014) |
| Status | Terminated |
| Reason | The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. |
| Root cause | Software design |
| Action | Radiometer sent a Field Safety Notice dated December 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. What you should do short term: " Please ensure that the operator always closes the inlet when prompted by the analyzer, as per the labeling. " In case the inlet, by mistake, is not closed as per the labeling, please ensure that the following is carried out before measuring a patient sample: " Close the inlet and wait for the analyzer to go to READY (approximately five minutes) " Open the inlet and then close |
| Quantity | 5002 units |
| Distribution | Worldwide Distribution -USA including CT, MN, FL, CA, PA, NY, KY, MA, WA, MI, TX, NC, IL, OH, SC, OK, NJ, MD, VA, UT, AL, NM, GA, LA, OR, IN, WI, AZ, ND, CO, MO, WV, ID, TN, VT, NE, IA, NH, MS, ME, AR and Internationally to Canada, Australia, Austria , China, Czech Republic, Denmark, Estonia, Lithua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120197 | ABL90 FLEX Radiometer Medical Aps, Mar 19, 2012 |