ARCHITECT 1P31-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740001742), received between Nov 27, 2019 and May 4, 2020 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K102699); they may or may not involve this specific model.

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.

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.

• MalfunctionMay 4, 2020High Test Results; High Test Results

  ABBOTT IDENTIFIED THAT SAMPLES TESTED FOR ARCHITECT STAT HIGH SENSITIVE TROPONIN-I AND STAT HIGH SENSITIVITY TROPONIN-I ASSAYS (LN 3P25 AND LN 2R98) MAY SHOW INTERACTION WHEN PROCESSED DIRECTLY AFTER THE ARCHITECT IGENTAMICIN (LN 1P31-25) ASSAY AND PATIENT RESULTS MIGHT BE IMPACTED. THERE HAS BEEN NO REPORTED HARM OR IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10020975 ↗
• MalfunctionNov 27, 2019Leak/Splash; Smoking; Noise, Audible; Leak/Splash; Smoking; Noise, Audible

  THE CUSTOMER REPORTED THAT WHEN TAKING OUT THE ARCHITECT GENTAMICIN CONTAINER FROM THE ANALYZER THERE WAS A "SMALL EXPLOSION/POPPING NOISE". THE TECHNICIAN SAW VAPOR/SMOKE WITHOUT ANY SMELL COMING FROM THE CONTAINER. A FEW SECONDS LATER, THE TECHNICIAN REALIZED THAT SHE HAD A SPLASH ON THE OUTER PART OF HER LEFT WRIST, AND IT WAS A LITTLE IRRITATED, AND ON THE RING FINGER OF HER RIGHT HAND SHE FELT SOMETHING LIKE A KIND OF EMBEDDED SPLINTER. THE AFFECTED AREAS WERE WASHED BUT NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

  Patient problems: Skin Irritation

  MAUDE report 9384445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102699. One submission often covers many models, so check the product and lot details in each record.

• Z-2117-2020 · Apr 24, 2020 · Open, Classified
  ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin t