Recall Z-1008-2012 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Radiometer America Inc
S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
| Date | Feb 13, 2012 (initiated Dec 16, 2011) |
| Status | Terminated |
| Reason | When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results. |
| Root cause | Device Design |
| Action | Radiometer sent a Medical Device Recall letter dated December 28, 2011 to their customers. The letter provided details on the affected devices, description of the problem and actions to be taken. The firm instructed their customers to immediately examine their stock and return any remaining product to Raiometer America Inc. for disposal. The letter states that Radiometer will replace all bottles of the affected lots, at no charge. Customers were asked to complete the attached Recall Response Fax Form and fax to 800-736-0601. For questions regarding the Recall contact Radiometer America |
| Quantity | 7 boxes/6/175mL bottles |
| Distribution | Nationwide Distribution (USA) including the states of: NY, PA and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051968 | ABL8X7 FLEX Radiometer Medical Aps, Oct 16, 2006 |