The investigation determined that lower and higher than expected vitros dgxn and phyt results were obtained from non-vitros biorad control, lot 27750 using vitros dgxn slide lot 1924-0261-1419, vitros phyt slide lots 2621-0177-0738, 2621-0178-3213, and 2621-0178-3878 tested on two different vitros 5600 integrated systems.Vitros 56002659 system: vitros dgxn slide lot 1924-0261-1419.Biorad l3 dgxn result of 1.99 ng/ml vs.An expected result of 2.94 ng/ml.Vitros phyt slide lot 2621-0177-0738.Biorad l2 phyt results of 4.47, 16.76, 17.06 and 16.23 ug/ml vs.An expected result of 13.49 ug/ml.Biorad l3 phyt results of 10.54, 10.80, 12.05, 10.58, 34.90, 33.16, 33.67, 21.24, 17.25, 17.86, 10.72, 8.07, 9.14, 12.02, 15.14, 16.15, 21.06, 20.06, 14.69, 13.27, 18.82, 12.67, 20.91, 21.19, 14.53, 19.42, 5.14, 15.72, 15.99, 16.02, 16.42, 20.37, 4.04, 17.85, 16.20, 15.80 and 16.61 ug/ml vs.An expected result of 27.21 ug/ml.Vitros phyt slide lot 2621-0178-3213.Biorad l3 phyt results of 17.20, 21.26, 23.05, 23.82, 24.39, 15.44 and 17.61 ug/ml vs.An expected result of 35.0 ug/ml.Vitros phyt slide lot 2621-0178-3878.Biorad l3 phyt results of 19.68, 15.27, 21.46, 16.03, 16.39, 19.67, 16.29, 16.57, 16.37, 19.38, 18.82, 18.65 and 19.55 ug/ml vs.An expected result of 35.0 ug/ml.Vitros 56003892 system: vitros dgxn slide lot 1924-0261-1419.Biorad l3 dgxn results of 1.67, 1.92, 1.99, 1.76, <0.40, 0.50, 1.88, 1.98, 0.50, 0.85 and 0.96 ng/ml vs.An expected result of 2.94 ng/ml.Vitros phyt slide lot 2621-0177-0738.Biorad l2 phyt results of 17.01, 16.56, 16.63, 10.29, 9.79, 16.68, 16.49, and 16.45ug/ml vs.An expected result of 13.49 ug/ml.Biorad l3 phyt results of 15.42, 33.38, 33.26, 33.17, 14.13, 11.90, 14.71, 19.61, 10.90, 13.19, 10.78, 19.38, 4.39, 12.70, 6.90, 11.82, 9.83, 17.06, 7.77, 11.10, 18.89, 18.53, 16.78, 14.52, 14.50, 19.58, 18.76, 7.70, 33.44, 9.43, 9.91, 10.36, 9.76, 20.38, 16.49, 11.46, 16.03, 16.52, 15.21, 12.38, 18.92, 20.57, 21.37, 17.44, 4.88, 5.09, 20.33, 16.48, 21.65, 5.86, 13.81, and 15.60ug/ml vs.An expected result of 27.21 ug/ml.Vitros phyt slide lot 2621-0177-3213 results.Biorad l3 phyt results of 19.28, 21.82, 23.42, 22.91, 22.61, 22.02 and 18.42 ug/ml vs.An expected result of 35.0 ug/ml.Vitros phyt slide lot 2621-0178-3878 results: biorad l2 phyt results of 12.67 and 12.47 ug/ml vs.An expected result of 15.9 ug/ml.Biorad l3 phyt results of 18.00, 22.64, 18.13, 18.46 and 17.14 ug/ml vs.An expected result of 35.0 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The affected quality control samples were non-patient quality control samples.The customer made no indication that patient sample results were affected.There were no reported allegations of patient harm.This report is number three of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4).
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