ARCHITECT 9P18-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740121075), received between Oct 24, 2016 and Dec 15, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2016Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY WERE MADE AWARE OF A PRODUCT RECALL FROM AN ABBOTT COMPETITOR REGARDING ASSAY INTERFERENCE FROM N-ACETYL CYSTEINE (NAC) WITH ASSAYS INCLUDING GLUCOSE, LACTIC ACID, URIC ACID AND TRIGLYCERIDES. UPON DOING RESEARCH ON THE (B)(4), THE CUSTOMER FOUND SIMILAR RECALLS FROM OTHER COMPETITORS (BECKMAN COULTER, ROCHE AND SIEMENS) OVER THE PAST 18 MONTHS BUT NOTHING FROM ABBOTT LABORATORIES. THE CUSTOMER INQUIRED AS TO WHETHER ABBOTT HAS ANY INFORMATION REGARDING SIMILAR INTERFERENCE WITH ARCHITECT ASSAYS. NO DISCREPANT ARCHITECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Misdiagnosis

  MAUDE report 6174867 ↗
• MalfunctionNov 29, 2016Low Test Results; Low Test Results

  THE CUSTOMER RECEIVED A COMMUNICATION FROM ROCHE REGARDING ASSAY INTERFERENCE FROM ACETAMINOPHEN (PARACETAMOL) AND ITS METABOLITES. THE CUSTOMER INQUIRED AS TO WHETHER ABBOTT LABORATORIES HAS ANY INFORMATION REGARDING INTERFERENCE FROM ACETAMINOPHEN AND ITS METABOLITES INCLUDING N-ACETYL CYSTEINE (NAC) WITH ARCHITECT ASSAYS INCLUDING LACTIC ACID. NO DISCREPANT ARCHITECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Misdiagnosis

  MAUDE report 6133234 ↗
• MalfunctionOct 25, 2016Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY WERE MADE AWARE OF INFORMATION REGARDING ASSAY INTERFERENCE CAUSED BY THE DRUGS N-ACETYL CYSTEINE (NAC), ACETAMINOPHEN AND METAMIZOL WITH METHODS USING PEROXIDASE AND H2O2. OTHER MANUFACTURERS SUCH AS ROCHE HAVE ACKNOWLEDGED THE INTERFERENCE. THE CUSTOMER INQUIRED AS TO WHETHER ABBOTT LABORATORIES HAS ANY INFORMATION REGARDING SIMILAR INTERFERENCE WITH ARCHITECT ASSAYS. NO DISCREPANT ARCHITECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Misdiagnosis

  MAUDE report 6055183 ↗
• MalfunctionOct 24, 2016Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY WERE MADE AWARE OF AN ALERT REGARDING SEVERAL SIEMENS ASSAYS AND INTERFERENCE IN PATIENTS TREATED WITH NAC. THE CUSTOMER INQUIRED AS TO WHETHER ABBOTT LABORATORIES HAS ANY CONCERNS REGARDING SIMILAR INTERFERENCE WITH ARCHITECT ASSAYS INCLUDING LACTIC ACID. NO DISCREPANT ARCHITECT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Misdiagnosis

  MAUDE report 6052050 ↗