Corrective action and recall for AutoVue Innova and AutoVue Ultra software version 1.02, Ortho
2006.06.16
Product group In-vitro diagnostics
Reference 01131/06
Corrective action and recall of Ortho for AutoVue Innova and AutoVue Ultra software version 1.02 because of indeterminate antibody screening results when using 0.8 % reagent red blood cells. Customers were informed about the problem and how to avoid it. A new software version will be developed.