ARCHITECT 06R8620Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380740191832), received between May 28, 2020 and Sep 8, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED DISCREPANT ARCHITECT SARS COV-2 IGG RESULTS WHEN PERFORMING A LOT-TO-LOT COMPARISON. THE CUSTOMER STATED 17 SAMPLES WERE RUN OVER THE COURSE OF 3 DAYS, HOWEVER ONLY HAD 5 SAMPLES TO PROVIDE. THE REFERENCE RANGE: < 1.40 S/CO IS NEGATIVE, >/= 1.40 S/CO IS POSITIVE. SAMPLE #1: 0.51 S/CO (PREVIOUS LOT) / 0.29 S/CO (NEW LOT) SAMPLE #2: 1.84 S/CO (PREVIOUS LOT) / 0.90 S/CO (NEW LOT) SAMPLE #3: 15.65 S/CO (PREVIOUS LOT) / 9.06 S/CO (NEW LOT) SAMPLE #4: 2.46 S/CO (PREVIOUS LOT) / 1.62 S/CO (NEW LOT) SAMPLE #5: 0.04 S/CO (PREVIOUS LOT) / 0.02 S/CO (NEW LOT) THE CUSTOMER BELIEVES THAT THE RESULTS GENERATED FROM THE NEW REAGENT LOT ARE QUESTIONABLE. ONE SAMPLE (SAMPLE #2) OUT OF THE 5 SAMPLES PROVIDED WAS FALSE NEGATIVE FOR SARS COV-2 IGG. THE OTHER 4 SAMPLES WERE REVIEWED AND DO NOT MEET REPORTABILITY CRITERIA. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15386962 ↗
• MalfunctionAug 15, 2022False Positive Result; False Positive Result

  IN A LITERATURE ARTICLE BY JOSEPH SIMONSON, ET AL., ¿THE CLINICAL IMPACT OF THE COVID 19 PANDEMIC FIRST WAVE ON PATIENTS WITH CYSTIC FIBROSIS IN NEW YORK¿, A RETROSPECTIVE COHORT STUDY INCLUDING PEOPLE WITH CYSTIC FIBROSIS IN NEW YORK FROM MARCH 1, 2020 TO AUGUST 31, 2020 AT 12 ADULT AND PEDIATRIC CYSTIC FIBROSIS CENTERS. THE ABBOTT ARCHITECT (CMIA METHOD) REPORTED ONE FALSE POSITIVE ARCHITECT SARS-COV2 IGG IN A SAMPLE OF 1020 SPECIMENS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229374 ↗
• MalfunctionMay 27, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE SARS-COV-2 IGG RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 INITIAL RESULT GENERATED A NEGATIVE RESULT OF 0.04 S/CO, THE SAMPLE WAS SENT TO ANOTHER LABORATORY AFTER THE PHYSICIAN QUESTIONED THE RESULT AND GENERATED A POSITIVE RESULT OF >100 (UNKNOWN METHOD). THE PATIENT WAS REDRAWN ON (B)(6) 2022 SID (B)(6) AND GENERATED A NEGATIVE RESULT OF 0.03 S/CO ON THE ARCHITECT. THE NEW SAMPLE WAS NOT RETESTED AT ANOTHER LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523194 ↗
• MalfunctionMar 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED ON (B)(6) 2021 (REFERENCE RANGE: < 1.40 S/C = NEGATIVE, >/= 1.40 S/C = POSITIVE): SID (B)(6) = INITIAL RESULT = 1.33 S/C (NEGATIVE), REPEAT RESULT = 1.45 S/C (POSITIVE). THE CUSTOMER STATED THAT THE QUALITY CONTROL FOR SARS-COV-2 IGG ASSAY IS RUNNING LOW BUT ARE STILL WITHIN RANGE OF THE PACKAGE INSERT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441048 ↗
• MalfunctionMar 4, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE SARS-COV-2 IGG RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: >/= 1.40 INDEX (S/C) = POSITIVE): PATIENT 1: ON (B)(6) 2021, INITIAL RESULT = 0.05 INDEX (S/C), REPEAT AT A REFERENCE LAB ON THE ORTHO VITROS COVID-19 TOTAL AND IGG ANTIBODY (WHICH DETECTS THE S1 PROTEIN) = 20 S/C (REFERENCE RANGE: >/= 1.00 S/C = POSITIVE). THE PATIENT RECEIVED THE 2ND DOSE OF THE PFIZER VACCINE ON (B)(6) 2021 AND HAS NEVER EXPERIENCED ANY SYMPTOMS OR DIAGNOSED WITH COVID. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED FOR THE SECOND PATIENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412902 ↗
• MalfunctionNov 6, 2020False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THE CUSTOMER IS QUESTIONING DISCREPANT ARCHITECT SARS-COV-2 IGG RESULT FOR A MALE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED ON (B)(6) 2020: THE PATIENT RECENTLY TESTED NEGATIVE FOR SARS-COV-2 IGG ANTIBODY. IN (B)(6) 2020, THE PATIENT HAD TESTED POSITIVE FOR COVID-19. THE CUSTOMER IS QUESTIONING THAT THE RECENT RESULT IS FALSE NEGATIVE, OR THAT THE RESULT GENERATED IN MARCH IS FALSE POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10801230 ↗
• MalfunctionAug 21, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT SARS COV-2 IGG RESULT FOR A PATIENT. THE PATIENT HAD PREVIOUSLY TESTED POSITIVE FOR COVID IGG POSITIVE FROM ANOTHER SITE AND INSTRUMENTATION. THE CUSTOMER COULD NOT PROVIDE SPECIFIC DETAILS. THE PATIENT WAS DRAWN AT THIS CUSTOMER'S FACILITY ON (B)(6) 2020, SID (B)(6), GENERATED AN ARCHITECT SARS COV-2 IGG RESULT OF 1.35 S/C (NEGATIVE). THE CUSTOMER'S CUTOFF RANGE IS GREATER THAN OR EQUAL TO 1.4 S/C (POSITIVE). THE DOCTOR RECOMMENDED THE PATIENT GO TO (B)(6) TO BE TESTED IN 2 WEEKS. (B)(6) PERFORMS SARS COV-2 IGG TESTING ON THE ALINITY PLATFORM AND THE PATIENT SID (B)(6) GENERATED A POSITIVE RESULT (VALUE IS UNKNOWN). THE CUSTOMER REQUESTED THE (B)(6) SAMPLE TO BE SENT BACK TO THEIR FACILITY TO BE TESTED AND GENERATED A RESULT OF 1.32 S/C (NEGATIVE). THERE WAS NO IMPACTED TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10440020 ↗
• MalfunctionJul 27, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE SARS-COV-2 IGG RESULT FOR A WHITE MALE PATIENT, WHO HAD NO COVID-19 SYMPTOMS, ON AN ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (<1.4 INDEX (S/C) IS NEGATIVE, >/=1.4 INDEX (S/C) IS POSITIVE): SAMPLE ID (B)(6), COLLECTED ON (B)(6) 2020, INITIAL RESULT WAS 5.9 INDEX (S/C). PATIENT WAS RECOLLECTED ON (B)(6) 2020, SAMPLE ID (B)(6), INITIAL RESULT WAS 6.3 INDEX (S/C). THE SAMPLE WAS THEN SENT OUT ON (B)(6) 2020, TESTED ON (B)(6) 2020, USING A DIASORIN LIAISON IGG ANTIBODY TEST, INITIAL RESULT WAS <3.9, NO UNITS OF MEASURE WERE PROVIDED, RESULTS >15 ARE POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10329652 ↗
• MalfunctionJul 20, 2020False Negative Result; False Negative Result

  THE ACCOUNT GENERATED A FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULT ON A PATIENT. ON (B)(6) 2020, SID (B)(6) GENERATED ARCHITECT SARS-COV-2 IGG NEGATIVE (0.01 INDEX) BUT PCR IPSUM DX METHOD RESULT OF DETECTED. THE PATIENT, A (B)(6) YEAR OLD, FEMALE, CAUCASIAN, SHOWED ONSET OF SYMPTOMS OF SHORTNESS OF BREATH ON (B)(6) 2020. THE PATIENT CLINICAL HISTORY IS HYPERTENSIVE, THYROID DISEASE AND POST-MENOPAUSAL. IT IS UNKNOWN IF THE PATIENT IS IMMUNOCOMPROMISED. THE PATIENT WAS NOT ON IMMUNOSUPPRESSANTS OR CHEMOTHERAPEUTICS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10299094 ↗
• MalfunctionJul 17, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE SARS-COV-2 IGG RESULT FOR A (B)(6) FEMALE PATIENT, WITH MILD TO MODERATE COVID-19 SYMPTOMS, ON AN ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED(<1.40 INDEX (S/C) IS NEGATIVE, >/=1.40 INDEX (S/C) IS POSITIVE):SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 4.73 INDEX (S/C), REPEAT, ON (B)(6) 2020, WAS 4.67 INDEX (S/C). THE SAMPLE WAS ALSO TESTED AT (B)(6) CLINIC USING THE VITROS SARS-COV-2 IGG ASSAY AND IT WAS NEGATIVE. IT WAS NOTED THAT PATIENT TESTED NEGATIVE ON (B)(6) 2020 WITH A PCR RNA NASAL SWAB ASSAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292491 ↗
• MalfunctionJul 6, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NEGATIVE SARS-COV-2 IGG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A (B)(6) YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: LESS THAN 1.4 S/C = NEGATIVE): ON (B)(6) 2020 SID (B)(6) INITIAL RESULT = 0.66 S/C (NEGATIVE), REPEAT = 0.63 S/C (NEGATIVE), REPEAT ON ANOTHER COLLECTION TUBE DRAWN AT THE SAME TIME = 0.61 S/C (NEGATIVE). ON (B)(6) 2020 THERMOFISCHER QUANT PCR TEST WAS POSITIVE FOR N1 AND N2. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10237674 ↗
• MalfunctionJun 22, 2020False Negative Result; False Positive Result; False Negative Result; False Positive Result

  A NURSE PRACTITIONER ((B)(6) FEMALE) OBTAINED FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULTS. THE NURSE PRACTITIONER INDICATED SHE HAD THE CLASSIC SYMPTOMS AND TESTED POSITIVE WITH NP PCR SWAB. ON (B)(6) 2020 SAMPLE ID (B)(6) GENERATED A NEGATIVE RESULT ON ARCHITECT. ON (B)(6) 2020 A NEW SAMPLE (B)(6) GENERATED NEGATIVE RESULTS ON BOTH ARCHITECT AND DIASORIN. HOWEVER, ON (B)(6) 2020 A DONATION OF CONVALESCENT PLASMA WAS POSITIVE FOR IGG (METHOD UNKNOWN). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10179839 ↗
• MalfunctionJun 15, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NEGATIVE SARS-COV-2 IGG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A (B)(6) YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: LESS THAN 1.4 S/C = NEGATIVE): (B)(6) INITIAL RESULT = 0.66 S/C (NEGATIVE), REPEAT = 0.63 S/C (NEGATIVE), REPEAT ON ANOTHER COLLECTION TUBE DRAWN AT THE SAME TIME = 0.61 S/C (NEGATIVE). ON (B)(6) 2020 THERMOFISCHER QUANT PCR TEST WAS POSITIVE FOR N1 AND N2. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10152433 ↗
• MalfunctionJun 10, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ARCHITECT SARSCOV-2 IGG RESULT ON A PATIENT. THE PATIENT PRESENTED CO-VID 19 SYMPTOMS 2 MONTHS AGO AND TESTED POSITIVE FOR SARS COV-2 BY PCR METHOD. THE PATIENT THEN TESTED POSITIVE FOR THE ANTIBODY ON A LATERAL FLOW CARD (MANUFACTURER UNKNOWN). ON (B)(6) 2020 AND (B)(6) 2020 THE PATIENT SAMPLE WAS TESTED ON THE ARCHITECT I 1000SR ANALYZER AND GENERATED A NEGATIVE RESULT FOR ARCHITECT SARS-COV-2 IGG OF 0.6 S/C (< 1.4 S/C = NEGATIVE). THE SAMPLE WAS SENT TO (B)(6) GENERATING A NEGATIVE RESULT OF 0.6 S/C ON ANOTHER ARCHITECT ANALYZER. THE SAMPLE WAS SENT TO (B)(6) USING ANOTHER METHOD AND GENERATED A POSITIVE RESULT FOR IGG ANTIBODY DIRECTED AT THE SPIKE PROTEIN RECEPTOR BINDING DOMAIN (RBD) AND THE SAMPLE WAS NEGATIVE FOR IGM. THE CUSTOMER COULD NOT PROVIDE PATIENT VALUES OF THESE RESULTS AT THIS TIME. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140185 ↗
• MalfunctionJun 2, 2020False Negative Result; False Negative Result

  A PHYSICIAN REPORTED FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULTS ON ONE PATIENT VIA (B)(6) POST, THEREFORE, NO ADDITIONAL PATIENT INFORMATION IS CURRENTLY AVAILABLE. THE RESULTS PROVIDED: (B)(6) LAB SARS CORONAVIRUS 2 RNA BY PCR RESULT =POSITIVE AFTER 13 DAYS OF SYMPTOMS, SAMPLE COLLECTED (B)(6) 2020 / ARCHITECT SARS-COV-2 IGG RESULT=NEGATIVE AFTER 55 DAYS FROM SYMPTOM ONSET. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10110970 ↗
• MalfunctionMay 28, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE SARS-COV-2 IGG RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT WHO WAS CONFIRMED TO HAVE THE INFECTION DUE TO A POSITIVE ANTIGEN PCR RESULT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2020 RESULTS: ARCHITECT IGG (B)(4)= 1.19 S/CO NEGATIVE (GREATER OR EQUAL TO 1.4 S/CO = POSITIVE). BIOREFERENCE DIAZYME IGG = NEGATIVE (REFERENCE RANGE NOT PROVIDED). BIOREFERENCE DIAZYME IGM = POSITIVE (REFERENCE RANGE NOT PROVIDED). BIOREFERENCE DIASORIN IGG = 21 POSITIVE (GREATER OR EQUAL TO 15 = POSITIVE). ADDITIONAL DATA WAS ADDED TO THE TICKET: THE PATIENT WAS DRAWN AGAIN ON (B)(6) 2020 AND GENERATED NEGATIVE RESULTS ON THE ARCHITECT. THE CUSTOMER FURTHER INDICATED THE PATIENT'S PREVIOUS SAMPLE ON (B)(6) 2020, WHICH WAS USED IN A VERIFICATION STUDY AND NOT INTENDED FOR PATIENT MANAGEMENT, GENERATED THE FOLLOWING RESULTS: ARCHITECT IGG (B)(4) = 1.13 S/CO AND 1.22 S/CO ACROSS TWO ARCHITECT ANALYZERS. BIOREFERENCE DIAZYME IGG = NEGATIVE. BIOREFERENCE DIAZYME IGM = POSITIVE. BIOREFERENCE DIASORIN IGG = NOT TESTED. MT SINAI IGG = 960 (POSITIVE, UNITS OF MEASURE NOT PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10098985 ↗