The initial reporter stated on (b)(6) 2020 that they have received discrepant high nitrite results for an unspecified number of patient samples tested with combur 10 m test strips on a cobas u 411 analyzer.The reporter states that approximately every 10th patient sample will have a high nitrite result when tested, but when checking the sample sediment microscopically, no bacteria are visible.Bacterial cultures for these samples are negative.The issue occurred for "about two weeks" after starting use of test strip lot number 42219803.The specific date of the event is not known.The unused test strip nitrite test pads are white.After the affected samples are tested, the nitrite test pads appear to be pink visually.The u 411 analyzer serial number was requested, but not provided.
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