ARCHITECT 7K61-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740014179), received between May 9, 2017 and Sep 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT B12 RESULT FOR ONE PATIENT. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE INSTRUMENT WHICH GENERATED A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2022 INITIAL RESULT = > 2000 PG/ML, REPEAT RESULT = 107 PG/ML THE CUSTOMER REPORTED THE 107 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492108 ↗
• MalfunctionApr 1, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT B12 RESULTS FOR MULTIPLE SAMPLES WHEN COMPARED TO A REFERENCE LABORATORY. ADDITIONALLY, THE CUSTOMER NOTED THERE WAS A SHIFT IN QC RESULTS STARTING ON (B)(6) 2022. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 211 TO 1074 PG/ML, TEST DATE WAS (B)(6) 2022, UNITS OF MEASURE IS PG/ML): SID (B)(6) ARCHITECT RESULT = 315, ARUP RESULT = 200. SAMPLE 5: ARCHITECT RESULT = 360, ARUP RESULT = 255. SAMPLE 6: ARCHITECT RESULT = 383, ARUP RESULT = 273. SAMPLE 10: ARCHITECT RESULT = 405, ARUP RESULT = 254. SAMPLE 14: ARCHITECT RESULT = 371, ARUP RESULT = 235. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978736 ↗
• MalfunctionMay 9, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED RESULT WHILE USING THE ARCHITECT B12 ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA (PG/ML): SID (B)(4). INITIAL (B)(6) 2017: 522 RETESTS: (B)(6) 2017: 303 AND 4/15/17: 281.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553872 ↗