Corrective action of Roche for SnapPak
2004.12.23
Product group In-vitro diagnostics
Reference 02812/04
Corrective action of Roche for SnapPak (lot numbers 742211, 742511, 742821, 742921, 743131, 743211,743521, 744112 and 742420). Due to an improper sealing, KCl solution (reference solution) may mix with calibration solution, resulting in higher K and Cl concentrations in the calibration solution. This has an impact on the determination of K, Cl, Na, pH,Li und Ca. K and CL are the most affected. Customers were informed by phone of the leakage and the medical impact. Lots in the manufacturer's inventory were controled by noddestructive means. In addition, customers were advised to determine the K concentration in their laboratory to ensure product quality.
Advisory notice is only available in German language.
Corrective action of Roche for SnapPak , Download_VeroeffentlichtAm_EN