Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
Hazard
Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
What You Should Do
Remedy
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.
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Products
Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
- Brand
- Alfa Wassermann, Inc
- UPC
- Catalog Number: S1-32: Lot: A31, Exp. 2/2006 (Kit lot #F1458); A41, Exp. 1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C).
Units Affected
22,987 kits