ARCHITECT 8L92-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740017866), received between Jun 24, 2021 and Jun 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ABBOTT IDENTIFIED INTERNALLY THAT THE ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) LINEARITY SPECIFICATION WAS NOT BEING MET WHEN USING A-ALT REAGENT (LN 08L92) AS IT NEARS EXPIRATION ON THE ARCHITECT. THERE IS A POTENTIAL FOR > 10% UNDER-RECOVERY ON A-ALT SAMPLES GREATER THAN 1,200 U/L. ADDITIONALLY, IT WAS IDENTIFIED THAT THE ARCHITECT (LN 08L92) AND ALINITY C (LN 08P18) A-ALT ASSAYS WERE NOT MEETING BILIRUBIN INTERFERENCE CLAIMS WITH SAMPLES CONTAINING BILIRUBIN CONCENTRATIONS GREATER THAN 31 MG/DL. INTERNAL INTERFERENCE TESTING DEMONSTRATED A 10% SHIFT IN PATIENT RESULTS WITH SAMPLES CONTAINING BILIRUBIN CONCENTRATIONS GREATER THAN 31 MG/DL. THERE HAS BEEN NO REPORTED DELAY IN RESULTS OR PATIENT HARM AS A RESULT OF EITHER OF THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063140 ↗