ARCHITECT 1L79-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380740001414), received between May 18, 2017 and Jan 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (P050042); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 4, 2024Open, Classified

   Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

   Z-1479-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025False Negative Result; False Negative Result

  AN ABSTRACT BY T. BUI-BULLOCK, A. P. BROWN, M. BROWN, S. LAWLESS, B. ROEMMICH, N. W. ANDERSON, AND C. W. FARNSWORTH ¿COMPARISON OF THE ELECSYS HCV DUO ASSAY TO STANDARD OF CARE ALGORITHMIC TESTING¿, CLINICAL CHEMISTRY 70:S1 (2024) NOTED FALSE NEGATIVE ARCHITECT ANTI-HCV RESULTS ON FIVE PATIENTS THAT WERE POSITIVE BY THE ELECSYS HCV DUO ASSAY AND HCV-RNA TESTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177755 ↗
• MalfunctionJun 28, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT ANTI-HCV RESULTS FOR SEVERAL PATIENTS. THE FOLLOWING EXAMPLE WAS PROVIDED (>/=1.00 S/CO IS REACTIVE):SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6), WAS 1.05, REPEAT RESULTS, ON (B)(6), WERE 0.17 AND 0.19 S/CO.IT WAS NOTED THAT RIGHT BEFORE THE REACTIVE RESULT, A SYPHILIS RESULT WAS RUN, WHICH GAVE A NONREACTIVE RESULT OF 0.19. THE PHYSICIAN QUESTIONED THE REACTIVE ANTI-HCV RESULT, AS IT DID NOT MATCH THE PATIENT¿S HISTORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631985 ↗
• MalfunctionMar 11, 2024False Positive Result; High Test Results; False Positive Result; High Test Results

  ABBOTT HAS IDENTIFIED A POTENTIAL ISSUE FOR ARCHITECT ANTI-HCV AND ALINITY I ANTI-HCV REAGENT KITS. INTERNAL STUDIES WITH CUSTOMER RETURN SAMPLES CONFIRMED POTENTIAL INTERACTIONS THAT MAY LEAD TO FALSELY ELEVATED RESULTS WHEN PROCESSED AS BELOW ON THE SAME INSTRUMENT: ¿ARCHITECT SYPHILIS TP (LIST NUMBER 08D06) AND OR ARCHITECT ADVISEDX SARS-COV-2-IGG II (LIST NUMBER 06S60) PRECEDES ARCHITECT ANTI-HCV TESTING (LIST NUMBER 01L79). ¿ALINITY I SYPHILIS TP (LIST NUMBER 07P60) PRECEDES ALINITY I ANTI-HCV TESTING (LIST NUMBER 08P05). THERE IS POTENTIAL FOR FALSE ELEVATION OF PATIENT RESULTS, INCLUDING NONREACTIVE TO GRAYZONE, GRAYZONE TO REACTIVE AND NON-REACTIVE TO REACTIVE ARCHITECT AND ALINITY I ANTI-HCV PATIENT RESULTS WHEN ARCHITECT SYPHILIS TP/ ARCHITECT ADVISEDX SARS-COV-2-IGG II OR ALINITY I SYPHILIS TP PRECEDES ANTI-HCV TESTING. ALTHOUGH POTENTIAL INTERACTIONS MAY CAUSE FALSE ELEVATION OF RESULTS FOR SOME PATIENT SAMPLES, FURTHER STUDIES INCLUDING A RANDOMIZED SAMPLE POPULATION SHOWED THAT THE REQUIRED PERFORMANCE SPECIFICATIONS INCLUDING SPECIFICITY OF THE ARCHITECT AND ALINITY I ANTI-HCV ASSAYS WERE MET. THE CUSTOMERS WHO DO NOT UTILIZE BOTH THE ARCHITECT ANTI-HCV AND ARCHITECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876387 ↗
• MalfunctionMay 5, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A (B)(6) ARCHITECT ANTI-HCV RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (B)(6) IS GRAYZONE, (B)(6): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2021, WAS (B)(6), REPEAT RESULTS WERE (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11777468 ↗
• MalfunctionDec 27, 2019False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT ANTI-HCV RESULT FOR 1 PATIENT. A DIFFERENT SAMPLE FROM ANOTHER LABORATORY WAS REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526965 ↗
• MalfunctionDec 12, 2017False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NON-REACTIVE (0.68 S/CO) ARCHITECT ANTI-HCV RESULT FOR ONE SAMPLE (B)(6) . THE SAMPLE WAS RETESTED ON AN ALTERNATE REAGENT LOT GENERATING REACTIVE (1.05 AND 1.83 S/CO) AS WELL AS GRAYZONE (0.95 AND 0.96 S/CO) RESULTS. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED AND NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7110286 ↗
• MalfunctionMay 18, 2017False Negative Result; False Negative Result

  THE CUSTOMER REPORTS THAT THE POSITIVE CONTROL FOR THE ARCHITECT ANTI-HCV ASSAY IS READING NEGATIVE ON ONE OF THE ARCHITECT I1000SR ANALYZERS IN THE LAB. CONTROLS WERE WITHIN SPECIFICATIONS AT THE BEGINNING OF THE DAY. THE REAGENT PACK IN USE AT THAT TIME RAN OUT OF REAGENT AND THE ANALYZER SWITCHED OVER TO A NEW REAGENT PACK OF THE SAME LOT. CONTROLS WERE NOT RUN AGAIN UNTIL THE FOLLOWING DAY AT WHICH TIME THE OUT OF SPECIFICATION ISSUE WAS FOUND. THERE ARE NO ISSUES WITH ANY OTHER ANALYZER IN THE LAB OR WITH ANY OTHER ASSAYS ON THIS PARTICULAR ARCHITECT I1000SR ANALYZER. CUSTOMER SUPPORT RECOMMENDED SEVERAL TROUBLE SHOOTING PROCEDURES, WHICH THE CUSTOMER PERFORMED. AFTERWARDS, FOUR PREVIOUS SAMPLES TESTED SIX DAYS EARLIER WERE PULLED FOR RETESTING, TWO OF WHICH WERE POSITIVE AND TWO NEGATIVE. THE TWO NEGATIVE SAMPLES REMAINED NEGATIVE; HOWEVER, ONE OF THE PREVIOUS POSITIVE SAMPLES (5.83 S/CO) NOW READ NEGATIVE (0.65 S/CO). THIS PATIENT IS KNOWN TO BE ANTI-HCV REACTIVE. THE OTHER POSITIVE SAMPLE (12.77 S/CO) REMAINED POSITIVE BUT NOW READ AT 1.98 S/CO. THIS PATIENT IS ALSO KNOWN TO BE ANTI-HCV REACTIVE. CUSTOMER SUPPORT SUGGESTED FURTHER TROUBLESHOOTING PROCEDURES TO TRY. THE CUST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577049 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050042. One submission often covers many models, so check the product and lot details in each record.

• Z-1480-2024 · Mar 4, 2024 · Open, Classified
  Alinity i Anti-HCV Reagent Kit, List Number 08P0521
• Z-0413-2007 · Jan 2, 2007 · Terminated
  ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-2