Corrective action and recall for the Cystic Fibrosis v3 Genotype Assay from Celera Diagnostics
2006.10.24
Product group In-vitro diagnostics
Reference 02279/06
Corrective action and recall of Celera Diagnostics for the Cystic Fibrosis v3 Genotype Assay (all lot numbers), because Process Quality Values (PQV) can be edited and accepted by means of the GeneMapper software although these should be rejected according the instructions for use. Customers were informed about the problem, and how to avoid it. A new software-version will be developed.