ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated 10283341Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414553139), received between Jun 22, 2023 and Jun 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT DUE TO VARIABLE ALANINE AMINOTRANSFERASE (ALT) RESULTS OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA CHEMISTRY XPT INSTRUMENTS (IDENTIFIED AS CA1275001960196 AND CA1275001970197) USING ADVIA CHEMISTRY CONCENTRATED ALANINE AMINOTRANSFERASE (ALT_C) REAGENT, THE CUSTOMER DELAYED REPORTING OTHER TESTS ORDERED ON THE SAMPLE; THE CLINICIAN ALLEGED THE DELAY IN REPORTING RESULTS WAS A FACTOR THAT AFFECTED THE CARE OF A CLINICALLY DETERIORATING PATIENT. THE LABORATORY WAS RELEASING RESULTS FOR OTHER PATIENTS DURING THIS TIME. THE CUSTOMER REPORTED THAT AT THE TIME OF THE EVENT, BLOOD GAS RESULTS FROM ANOTHER INSTRUMENT WERE AVAILABLE TO THE CLINICIAN AND CALCIUM/MAGNESIUM AND SALINE IV WERE UNDERWAY. SINCE THE CUSTOMER DID NOT RELEASE THE UREA NITROGEN AND CREATININE RESULTS, THE CLINICIAN DID NOT HAVE THESE RESULTS FROM THE ADVIA CHEMISTRY XPT INSTRUMENTS. IT IS UNKNOWN WHY THE LABORATORY DID NOT PROMPTLY RELEASE THE RESULTS TO THE CLINICIANS. THE SAMPLE WAS COLLECTED AT 11:00 PM ON (B)(6) 2023 AND ARRIVED AT THE LABORATORY AT 11:03 PM ON (B)(6) 2023. THE UNFLAGGED RESULTS FOR ALL THREE ANALYTES, ALT, UREA NITROGEN AND CREATININE, WERE AVAILABLE AT 11:34 PM ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183296 ↗
• MalfunctionJun 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT DUE TO VARIABLE ALANINE AMINOTRANSFERASE (ALT) RESULTS OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA CHEMISTRY XPT INSTRUMENTS (IDENTIFIED AS CA1275001960196 AND CA1275001970197) USING ADVIA CHEMISTRY CONCENTRATED ALANINE AMINOTRANSFERASE (ALT_C) REAGENT, THE CUSTOMER DELAYED REPORTING OTHER TESTS ORDERED ON THE SAMPLE; THE CLINICIAN ALLEGED THE DELAY IN REPORTING RESULTS WAS A FACTOR THAT AFFECTED THE CARE OF A CLINICALLY DETERIORATING PATIENT. THE LABORATORY WAS RELEASING RESULTS FOR OTHER PATIENTS DURING THIS TIME. THE CUSTOMER REPORTED THAT AT THE TIME OF THE EVENT, BLOOD GAS RESULTS FROM ANOTHER INSTRUMENT WERE AVAILABLE TO THE CLINICIAN AND CALCIUM/MAGNESIUM AND SALINE IV WERE UNDERWAY. SINCE THE CUSTOMER DID NOT RELEASE THE UREA NITROGEN AND CREATININE RESULTS, THE CLINICIAN DID NOT HAVE THESE RESULTS FROM THE ADVIA CHEMISTRY XPT INSTRUMENTS. IT IS UNKNOWN WHY THE LABORATORY DID NOT PROMPTLY RELEASE THE RESULTS TO THE CLINICIANS. THE SAMPLE WAS COLLECTED AT 11:00 PM ON (B)(6) 2023 AND ARRIVED AT THE LABORATORY AT 11:03 PM ON (B)(6) 2023. THE UNFLAGGED RESULTS FOR ALL THREE ANALYTES, ALT, UREA NITROGEN AND CREATININE, WERE AVAILABLE AT 11:34 PM ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183233 ↗