Corrective action and Recall for Omni S system versions 2, 4 and 6 with CO-oximetry, Roche
2006.01.10
Product group In-vitro diagnostics
Reference 02832/05
Corrective action and Recall of Roche for Omni S system versions 2, 4 and 6 with CO-oximetry because of a malfunction of the QC -limits for hemoglobin derivatives. Customers were informed informed about the problem and how to avoid it. A new software version will be developed.
Advisory Notice is only available in German language.