Recall Z-1015-2010 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Radiometer America Inc
Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
| Date | Mar 5, 2010 (initiated Mar 26, 2009) |
| Status | Terminated |
| Reason | Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings. |
| Root cause | Other |
| Action | The recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be pla |
| Quantity | 50 membranes in U. S. distribution |
| Distribution | The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051968 | ABL8X7 FLEX Radiometer Medical Aps, Oct 16, 2006 |