FDA
Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
Inaccurate test results.
The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
Field correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006.