The customer received questionable results for 4-8 patient samples while using the urisys 1000 urine analyzer (serial number (b)(4)).The customer stated they were seeing differences between the meter and the laboratory results when testing the patients' urine.Of the data provided, it was noted that there was one patient whose result was erroneous.This patient's urine tested negative for blood on the meter but showed as 2+ for blood in the laboratory.It was stated that no treatment was received as a result of the test.Information concerning when the correct controls were last run, which result they believed to be correct, if any results were reported outside of the laboratory and which analyzer was used was requested, but it was not provided.It was stated that the strips have been stored correctly.The calibration had been run last on the urisys 1100 urine analyzer on (b)(6) 2016.They were not using the recommended controls on the meter.There was no adverse event reported.The suspect product was requested to be returned and the replacement product was sent.The retention material of lot 205 266 00 was measured with 0-artificial urine, 0-native and a blood- dilution series.There were no false results that were observed.
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