COBAS U 601 URINE ANALYZER

Additional Manufacturer Narrative

THE COBAS U PACK URINE TEST STRIPS LOT NUMBER USED WAS 86552500 WITH AN EXPIRATION DATE OF 30-APR-2026. THE QC OBTAINED EXPECTED RESULTS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE NEGATIVE RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED WITH COBAS U PACK URINE TEST STRIP ON A COBAS U 601 URINE ANALYZER. THE SAMPLE WAS TESTED ON THE COBAS U 601 URINE ANALYZER AND OBTAINED A NEGATIVE LEU (LEUCOCYTES) RESULT. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, PROMPTING THE CUSTOMER TO EXAMINE THE SAMPLE MICROSCOPICALLY AND OBSERVE NEUTROPHILS, SUGGESTING A POSITIVE RESULT. NO QUESTIONABLE RESULT WAS RELEASED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

THE REQUESTED PICTURES AND DATA WERE PROVIDED FOR THE INVESTIGATION. THE INVESTIGATION WAS PERFORMED AS FOLLOWS: THE RETENTION MATERIAL OF THE COBAS U PACK URINE TEST STRIPS, LOT NUMBER 86552500, WAS MEASURED ON A COBAS U 601 URINE ANALYZER WITH MATERIAL OF BIORAD LIQUICHECK LEVEL 2, LOT NUMBER 98052, AND MATERIAL OF BIORAD QUANTIFY PLUS LEVEL 2, LOT NUMBER 1002552. THE RETENTION MATERIAL OF THE COBAS U CUVETTE, LOT NUMBER 24103600, WAS MEASURED ON A COBAS U 701 ANALYZER WITH MATERIAL OF BIORAD LIQUICHECK LEVEL 2, LOT NUMBER 98052, AND MATERIAL OF BIORAD QUANTIFY PLUS LEVEL 2, LOT NUMBER 1002552. THE INVESTIGATION RESULTS WERE: NO FALSE NEGATIVE RESULTS ON THE COBAS U 601 URINE ANALYZER WERE OBSERVED. THE RESULTS FOR LEUKOCYTES FROM THE COBAS U 601 URINE ANALYZER AND U 701 ANALYZER WERE COMPARABLE. ALL MEASUREMENTS FULFILLED THE REQUIREMENTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.