ARCHITECT 1L82-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740115364), received between Aug 17, 2018 and May 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

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. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1842-2025 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT AUSAB RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL AUSAB RESULT = 19.64 MIU/ML, REPEAT RESULT = 0.48 MIU/ML, REPEAT RESULT ON ((B)(6)) 0.12 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309515 ↗
• MalfunctionMar 1, 2022False Positive Result; High Test Results; False Positive Result; High Test Results

  THE CUSTOMER OBSERVED FALSE POSITIVE AUSAB RESULTS GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR MULTIPLE PATIENTS, WHICH REPEATED NEGATIVE. THE FOLLOWING SIDS WERE PROVIDED: (B)(6) INITIAL RESULT = 32.4, (B)(6) INITIAL RESULT = 19.56, (B)(6) INITIAL RESULT = 35.76. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13632172 ↗
• MalfunctionFeb 15, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED (B)(6) ARCHITECT (B)(6) RESULTS ON FIVE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 (B)(6); ON (B)(6); ON (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8343928 ↗
• MalfunctionAug 17, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE ARCHITECT AUSAB ASSAY. THE CUSTOMER INDICATED THAT ON (B)(6) 2018, 8 PATIENT SPECIMENS GENERATED RESULTS BETWEEN 20-30 MIU/ML. NONE OF THE SPECIMENS HAVE BEEN RETESTED. THE CUSTOMER BELIEVES THE RESULTS MAY HAVE BEEN HIGH SINCE THEY WERE EXPECTING (B)(6) RESULTS. THE SPECIMENS WERE TESTED IMMEDIATELY AFTER CAP SURVEY SPECIMENS THAT ALSO GENERATED HIGH RESULTS, WHICH WERE EXPECTED TO BE LOWER AS WELL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793011 ↗