Recall Z-0816-2014 ยท JGS Electrode, Ion Specific, Sodium
Radiometer America Inc
ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
| Date | Jan 23, 2014 (initiated Oct 15, 2013) |
| Status | Terminated |
| Reason | RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results. |
| Root cause | Other |
| Action | Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field |
| Quantity | Total 3414 (US 524, CA 31, ROW 2859) |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, Aug 6, 2010 |