navify® Lab Operations 10382716001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336234402), received between May 29, 2025 and Jan 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Application Program Problem

  THERE WAS AN ALLEGATION OF A RESULT ISSUE FOR THE BENZODIAZEPINE ASSAY DUE TO THE NAVIFY LAB OPERATIONS SOFTWARE. A RULE IN THE SOFTWARE FOR THE ASSAY WAS TRIGGERED TWICE. THIS RULE TRANSFORMS THE RESULT TO NEGATIVE IF IT IS LESS THAN 0. OTHERWISE, IT SETS THE RESULT TO POSITIVE. THE OPTION 'WHEN VALUE CANNOT BE EVALUATED IS CONSIDERED FALSE' WAS ENABLED, AND THE SAME RULE WAS EXECUTED AGAIN. AS A RESULT, THE INITIAL OUTCOME WAS NEGATIVE, BUT SINCE IT COULD NOT BE EVALUATED AGAIN, IT WAS CONSIDERED FALSE, AND THE RESULT WAS SET TO POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979496 ↗
• MalfunctionNov 13, 2025Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION THAT REPORTS WERE NOT AVAILABLE DUE TO AN ISSUE WITH THE NAVIFY LAB OPERATIONS SOFTWARE. ALLEGEDLY, THE DOCTORS COULD NOT RETRIEVE THE BLOOD GAS TEST RESULTS FROM A RAPIDPOINT INSTRUMENT FOR A PATIENT. AT 12:24, AN ORDER FOR BLOOD GAS TESTING WAS GENERATED. THIS WAS REGISTERED CORRECTLY IN NAVIFY ® LAB OPERATIONS, AND THE RESULTS FOR THE ORDER WERE RECEIVED IN NAVIFY LAB OPERATIONS. BETWEEN 12:59 AND 13:11, THERE WERE FOUR ATTEMPTS TO PREVIEW THE ORDER THROUGH THE REPORT'S PREVIEW WEB SERVICE. ALLEGEDLY, A PDF WAS NOT GENERATED DUE TO A SOFTWARE ISSUE. AT 13:12, THE RESULTS FOR THE ORDER WERE MANUALLY VALIDATED BY A LABORATORY USER. DURING THIS TIME PERIOD, THE RESULTS REMAINED VISUALLY AVAILABLE IN THE INSTRUMENT AND IN THE SOFTWARE ITSELF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540645 ↗
• MalfunctionSep 17, 2025Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A NAVIFY LAB OPERATIONS SOFTWARE ISSUE. IT WAS ALLEGED THAT THE SOFTWARE IS SENDING A DILUTION FACTOR TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM WHICH WAS NEVER REQUESTED BY THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076139 ↗
• MalfunctionAug 11, 2025Application Program Problem; Application Program Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH A NAVIFY LAB OPERATIONS SOFTWARE PRODUCT. THE CUSTOMER ALLEGED THAT GLUCOSE RESULTS FOR A PATIENT SAMPLE WERE TRANSMITTED TO THEIR LABORATORY INFORMATION SYSTEM WITH A DIFFERENT (INCORRECT) IDENTIFICATION NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777221 ↗
• MalfunctionMay 29, 2025Application Program Problem; Application Program Problem

  ROCHE DIAGNOSTICS RECEIVED AN ALLEGATION OF INCORRECT SOFTWARE BEHAVIOR. THE MODULE IN QUESTION COMMUNICATES WITH THE INSTRUMENTS CONNECTED TO COBAS® INFINITY CENTRAL LAB. ITS FUNCTION IS TO EXCHANGE INFORMATION WITH ANY INSTRUMENT CONNECTED TO THE LIS. TEST RESULTS SENT BY AN INSTRUMENT CAN BE REPLACED WITH A SPECIFIC VALUE. RESULT BY RANGE REPLACEMENT CAN BE CONFIGURED TO BE TRIGGERED WHEN THE RECEIVED RESULT FALLS BETWEEN TWO VALUES, HAS ONE OR MORE ASSIGNED INSTRUMENT ALARMS, OR INCLUDES DILUTION INFORMATION. THESE THREE CONDITIONS CAN BE CONFIGURED TOGETHER FOR THE SAME TEST, FUNCTIONING AS AN AND PARAMETER, OR SEPARATELY, FUNCTIONING AS AN OR PARAMETER. THE ISSUE IS RELATED TO A SOFTWARE PROBLEM LEADING TO AN UNEXPECTED BEHAVIOR. WHEN THE RANGE RESULT MODIFICATION IS CONFIGURED FOR A SPECIFIC FLAG, AND RESULTS ARE SENT WITH THAT SAME FLAG, THE SYSTEM DOES NOT TRIGGER THE MODIFICATION, AND INSTEAD SAVES THE FLAG AS THE RESULT. NO PATIENTS WERE HARMED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106323 ↗