Recall Z-0178-2014 ยท CJY Azo Dye, Calcium
SEPPIM SAS
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Se
| Date | Nov 7, 2013 (initiated Sep 4, 2013) |
| Status | Terminated |
| Reason | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. |
| Root cause | Device Design |
| Action | ELITech Group of Bothell, WA sent an Urgent: Product Recall Notice dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: " Laboratories must not use plasma for the determination of total calcium when using this product. The product can still be used to determine total calcium with serum sample. " ELITech Clinical Systems SAS has revised the package insert and kit box label for the CALCIUM ARSENAZO reagent reference CALA-0250. All mentions of the use of the plasma will be remo |
| Quantity | 47 kits in US and 48 kits in Sweden |
| Distribution | Worldwide Distribution - US including the states of KY and UT and the country of Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH Elitechgroup, Jun 21, 2011 |