ARCHITECT 4P52-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740102746), received between Apr 29, 2022 and Jun 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 9, 2022Open, Classified

   There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

   Z-1454-2022 · Root cause: Under Investigation by firm · FDA record ↗

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 23, 2022High Test Results; High Test Results

  THROUGH INTERNAL DATA ANALYSIS, ABBOTT HAS IDENTIFIED THAT FOR THE ARCHITECT HEMOGLOBIN A1C (A1C), LN 04P52-20, AND ALINITY C HBA1C, LN 08P43-20 AND 08P43-77, REAGENT KITS THE CURRENT SET VALUE FOR LOW LINEARITY RANGE FOR TOTAL HEMOGLOBIN IS TOO LOW WHEN ANALYZING WHOLE BLOOD OR HEMOLYSATE SAMPLES WITH POOR SAMPLE INTEGRITY, DUE TO MICRO-CLOTS AND PARTICULATE MATTER, ASSOCIATED WITH LOW TOTAL HEMOGLOBIN VALUES. THIS MAY LEAD TO THE POTENTIAL FOR WHOLE BLOOD %HBA1C RESULTS TO BE ERRATIC. THE ISSUE HAS THE POTENTIAL TO RESULT IN FALSELY ELEVATED HEMOGLOBIN %A1C AND HEMOGLOBIN A1C PATIENT RESULTS. THERE HAS BEEN NO REPORTED ADVERSE IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787869 ↗
• MalfunctionApr 29, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED SPLASH FROM ARCHITECT HBA1C REAGENT INTO EYES WHEN TRYING TO REPLACED EMPTY REAGENT ON ARCHITECT C8000 PROCESSING MODULE. THE CUSTOMER STATES SLIPPED THE HBA1C BOX OUT OF HER HAND WHEN TRYING TO REPLACE EMPTY CONTAINER. THE HBA1C REAGENT SPLASHED INTO THE CUSTOMER EYES. THE CUSTOMER WAS WEARING PPE AT THE TIME OF INCIDENT BUT DID NOT WEAR SAFETY GLASSES AT THAT TIME. THE EYES WERE CLEANED AND RINSED WITH WATER. THERE WAS NO EYE IRRITATION, REDNESS OR ITCHING AND NO OTHER TREATMENT PROVIDED BY PHYSICIAN. NO IMPACT TO OPERATOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250283 ↗