ARCHITECT 6L21-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740011093), received between Dec 28, 2017 and Mar 6, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K063329); 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. 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.

• MalfunctionMar 6, 2019False Negative Result; False Negative Result

  THE CUSTOMER REPORTED IMPRECISE AND A (B)(6) RESULT FOR ONE PATIENT. THE PATIENT'S SAMPLES (SAMPLE IDS (B)(6)) GENERATED ONE (B)(6) RESULT OF (B)(6) AND MULTIPLE (B)(6) RESULTS RANGING FROM (B)(6) TO (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8396199 ↗
• MalfunctionSep 6, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY (B)(6) RESULTS WHILE USING ARCHITECT (B)(6) REAGENTS. THE CUSTOMER STATED THE SPECIMEN DRAWN ON (B)(6) 2018 AND TESTED ON (B)(6) 2018 WAS INITIALLY (B)(6) AND REPEAT USING A DILUTED SPECIMEN (1:2 AND 1:10) WAS (B)(6); HOWEVER, NO SPECIFIC VALUES WERE PROVIDED. REPEAT OF THE SPECIMEN AT ANOTHER FACILITY USING THE ORTHO VITROS METHOD WAS (B)(6), NO SPECIFIC VALUES WERE PROVIDED. THE PATIENT WAS PREVIOUSLY (B)(6) FOR (B)(6) ON (B)(6) 2018 AND (B)(6) 2018 WHEN TESTED AT ANOTHER HOSPITAL USING ANOTHER METHOD (ORTHO VITROS). THE (B)(6) 2018 SPECIMEN WAS ALSO (B)(6) WHEN TESTED BY THE STATE OF (B)(6) AND THE (B)(6); HOWEVER, THE METHODS USED AND RESULTS VALUES WERE NOT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7850698 ↗
• MalfunctionDec 28, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED (B)(6) ARCHITECT HAVAB-M RESULTS ON ONE PATIENT. THE RESULTS PROVIDED FOR THE PATIENT DIAGNOSED WITH WALDENSTROM'S MACROGLOBULINEMIA: (B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7150850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063329. One submission often covers many models, so check the product and lot details in each record.

• Z-2413-2011 · Apr 20, 2011 · Terminated
  ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adul
• Z-1596-2010 · Dec 30, 2009 · Terminated
  ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and