Recall Z-0732-2014 ยท CJY Azo Dye, Calcium
Vital Diagnostics, Inc.
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
| Date | Jan 14, 2014 (initiated Aug 29, 2013) |
| Status | Terminated |
| Reason | High positive calcium bias on plasma sample versus results on serum |
| Root cause | Device Design |
| Action | Vital Diagnostics issued a Recall Notice dated August 29, 2013, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use plasma for the determination of total calcium when using the affected product. The use of serum is acceptable, thus the product can still be used to determine total calcium with this sample type. Vital Diagnostics released a corection to the package insert for the Envoy Calcium Reagent. Customers with the affected product in their laboratory, were instr |
| Quantity | 395 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120626 | EON CALCIUM REGENT Vital Diagnostics (Manufacturing) Ptyltd, Aug 22, 2012 |