Corrective action for ProC Global, Dade Behring
2004.12.28
Product group In-vitro diagnostics
Reference 02890/04
Dade Behring settles a field corrective action of ProC Global lot number 543227 and 543228. The manufacturer has observed that once the affected lots of ProC Global are used for the determination of factor V Leiden in conjunction with coagulation factor V-deficient plasma a higher than expected rate of false negative results could be observed. The manufacturer advised customers that the affected lots cannot be used for the determination of factor V Leiden in conjunction with factor V-deficient plasma. Furthermore, the manufacturer recommends that all samples from patients at risk for thrombosis which previously tested negative for factor V Leiden deficiency should be retested using an alternative lot of ProC Global.
Corrective action for ProC Global, Dade Behring , Download_VeroeffentlichtAm_EN