The meter was returned.The test strips were not returned.The tray was dirty on the meter and the downholder piece was missing.Since the downholder piece was missing and the tray was dirty on the customer's returned meter, a tray from the investigation unit was used for testing the customer's meter.The retention material of lot 21650700 was measured on the customer's urisys 1100 and a urisys 1100 from the investigation unit with native urine, a nitrite-dilution-series, and was visually checked according to the testing plan.The results of the measurements fulfill the requirements.No false positive results were observed.Since the customer did not return the test strips, the investigation could not be completed.The investigation was unable to find a definitive root cause.
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