ARCHITECT 07K6337Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740144838), received between Nov 6, 2018 and Dec 9, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionDec 9, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT FREE T3 RESULTS FOR 9 PATIENTS, WHILE COMPARING RESULTS BETWEEN 2-POINT CALIBRATOR AND 6-POINT CALIBRATOR. THE CUSTOMER NOTICED THAT THE GENERATED RESULTS WERE INCONSISTENT WITH TSH/FT4 RESULTS. THE FOLLOWING DATA WAS GENERATED: SID (B)(6): 2.56 (CURRENT RESULT), 2.88 (PREVIOUS RESULT), 2.064 (TSH), AND 12.27 (FREE T4). SID (B)(6): <2.3 (CURRENT RESULT), 2.86 (PREVIOUS RESULT), 45.216 (TSH), AND 5.15 (FREE T4). SID 51319763: 2.47 (CURRENT RESULT), 3.82 (PREVIOUS RESULT), 1.67 (TSH), AND 17.07 (FREE T4). SID (B)(6): 2.43 (CURRENT RESULT), 3.58 (PREVIOUS RESULT), 0.39 (TSH), AND 12.64 (FREE T4). SID (B)(6): 2.47 (CURRENT RESULT), 4.25 (PREVIOUS RESULT), 1.329 (TSH), AND 9.63 (FREE T4). SID (B)(6): 2.37 (CURRENT RESULT), 3.36 (PREVIOUS RESULT), 0.385 (TSH), AND 11.71 (FREE T4). SID (B)(6): 2.55 (CURRENT RESULT), 3.23 (PREVIOUS RESULT), 0.13 (TSH), AND 15.67 (FREE T4). SID (B)(6): <2.33 (CURRENT RESULT), 2.88 (PREVIOUS RESULT), 0.425 (TSH), AND 11.91 (FREE T4). SID (B)(6): 2.56 (CURRENT RESULT), 4.31 (PREVIOUS RESULT), 0.232 (TSH), AND 12.46 (FREE T4). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9437758 ↗
• MalfunctionJan 4, 2019Low Readings; Low Readings

  CUSTOMER REPORTED A NEGATIVE BIAS ON PATIENT SAMPLES AFTER MOVING FROM THE 2PT ASSAY TO THE 6PT ASSAY FOR ARCHITECT FREE T3. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8218614 ↗
• MalfunctionNov 20, 2018Low Test Results; Low Test Results

  THE ACCOUNT OBSERVED FALSELY DEPRESSED ARCHITECT FREE T3 RESULTS. THE ACCOUNT DOES NOT RUN THE VITAMIN D ASSAY. AFTER TROUBLESHOOTING, THE ACCOUNT STATED THE ARCHITECT FREE T3 AND TOTAL T3 RESULTS ARE ONLY CONSISTENT WHEN PROCESSED SEPARATE AND ROUTINE AFTER THE DAILY MAINTENANCE. THE FOLLOWING FREE T3 RESULTS WERE PROVIDED: (B)(6): 2.81 PG/ML, RETEST 2.76 PG/ML; (B)(6): 1.58 PG/ML, RETEST 2.5 PG/ML (RETESTED ON DIFFERENT EQUIPMENT); (B)(6): <1.5 PG/ML, RETEST 2.23 PG/ML (RETESTED ON DIFFERENT EQUIPMENT); (B)(6): 2.02 PG/ML, RETEST 2.06 PG/ML; (B)(6): 1.96 PG/ML, RETEST 2.23 PG/ML; (B)(6): 2.56 PG/ML, RETEST 3.22 PG/ML; (B)(6): 2.12 PG/ML, RETEST 2.5 PG/ML; (B)(6): 2.21 PG/ML, RETEST 2.35 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8091986 ↗
• MalfunctionNov 6, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT FREE T3 RESULTS WHILE COMPARING RESULTS ON THE 2 POINT AND 6 POINT ASSAYS. THE CUSTOMER INDICATED THE 6 POINT ASSAY GENERATED 2.53 PMOL/L AND THE 2 POINT ASSAY GENERATED 3.41 PMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8042356 ↗