Corrective action and recall of Ortho Clinical Diagnostics for AutoVue Innova/Ultra
2005.12.22
Product group In-vitro diagnostics
Reference 03110/05
Corrective action and recall of Ortho Clinical Diagnostics for AutoVue Innova/Ultra (Software version 1.02) because under certain circumstances the link between the samples and the results generated can be lost and as a result of this disruption some of the results generated will not be used in the final interpretation of the test results. Customers were informed about the problem and how to avoid it. A new software version will be developed.