ARCHITECT 2P36-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380740003890), received between Jul 30, 2018 and Mar 26, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionMar 26, 2025False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT HIV AG/AB COMBO RESULTS GENERATED ON THE ARCHITECT I2000SR INSTRUMENT FOR ONE SAMPLE. THE SAMPLE WAS REPEATED IN DUPLICATE ON ANOTHER ANALYZER AND THE RESULTS WERE REACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697941 ↗
• MalfunctionSep 21, 2023False Positive Result; False Positive Result

  A LITERATURE ARTICLE BY TALIA WALL, ¿A CASE OF A FALSE POSITIVE HIV ANTIGEN/ANTIBODY SCREEN IN A PREGNANT WOMAN AT DELIVERY AND THE CLINICAL IMPORTANCE OF REVIEWING SIGNAL-TO-CUTOFF RATIO VALUES¿, IDCASES 33:E01819 (JUNE 15, 2023), REPORTED A CASE OF FALSE REPEAT REACTIVE ARCHITECT HIV AG/AB COMBO RESULTS ON A MOTHER WHO CAME TO THE LABOR AND DELIVERY UNIT FOR A SCHEDULED INDUCTION OF LABOR DUE TO LARGE FETAL SIZE AT A GESTATIONAL AGE OF 40 WEEKS 0 DAY. THE MOTHER DID NOT HAVE DOCUMENTED THIRD TRIMESTER RESULT FOR HIV AND WAS THEREFORE SCREENED UPON PRESENTATION FOR LABOR AND DELIVERY. THE MOTHER WAS CONSIDERED LOW RISK OF CONTRACTING HIV SINCE THERE WERE THREE DOCUMENTED NONREACTIVE HIV SCREENING TESTS OVER THE COURSE OF HER PREVIOUS PREGNANCIES. THE ARCHITECT HIV AG/AB SCREENING TEST REVEALED A REPEATEDLY REACTIVE RESULT. SINCE THE LIKELIHOOD OF PREVIOUS HIV EXPOSURE IN THE MOTHER WAS LOW, THE MEDICAL TEAM ASSUMED A POSSIBLE LABORATORY ERROR AND CONTINUED THE AUGMENTATION OF LABOR WITH PITOCIN. PER THE HOSPITAL PROTOCOL, A FRESH BLOOD SAMPLE WAS COLLECTED FROM THE MOTHER AND A SECOND ARCHITECT HIV AG/AB COMBO SCREENING TEST WAS PERFORMED AND THE RESULT WAS REPEAT REACTIVE. BOTH S

  Patient problems: Insufficient Information

  MAUDE report 17787899 ↗
• MalfunctionSep 21, 2023False Positive Result; False Positive Result

  A LITERATURE ARTICLE BY TALIA WALL, ¿A CASE OF A FALSE POSITIVE HIV ANTIGEN/ANTIBODY SCREEN IN A PREGNANT WOMAN AT DELIVERY AND THE CLINICAL IMPORTANCE OF REVIEWING SIGNAL-TO-CUTOFF RATIO VALUES¿, IDCASES 33:E01819 (JUNE 15, 2023), PRESENTED A CASE OF FALSE REPEAT REACTIVE ARCHITECT HIV AG/AB COMBO RESULTS ON A 25-YEAR-OLD WOMAN WHO CAME TO THE LABOR AND DELIVERY UNIT FOR A SCHEDULED INDUCTION OF LABOR DUE TO LARGE FETAL SIZE AT A GESTATIONAL AGE OF 40 WEEKS 0 DAY. THE PATIENT DID NOT HAVE DOCUMENTED THIRD TRIMESTER RESULT FOR HIV AND WAS THEREFORE SCREENED UPON PRESENTATION FOR LABOR AND DELIVERY. THE PATIENT WAS CONSIDERED LOW RISK OF CONTRACTING HIV SINCE THERE WERE THREE DOCUMENTED NONREACTIVE HIV SCREENING TESTS OVER THE COURSE OF HER PREVIOUS PREGNANCIES. PITOCIN WAS INITIATED AND A FEW HOURS LATER THE ARCHITECT HIV AG/AB SCREENING TEST REVEALED A REPEATEDLY REACTIVE RESULT. SINCE THE LIKELIHOOD OF PREVIOUS HIV EXPOSURE IN THIS PATIENT WAS LOW, THE MEDICAL TEAM ASSUMED A POSSIBLE LABORATORY ERROR AND CONTINUED THE AUGMENTATION OF LABOR WITH PITOCIN. PER THE HOSPITAL PROTOCOL, A FRESH BLOOD SAMPLE WAS COLLECTED FROM THE PATIENT AND A SECOND ARCHITECT HIV AG/AB COMBO SCREENING

  Patient problems: Insufficient Information

  MAUDE report 17787753 ↗
• InjuryNov 27, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HIV AG/AB COMBO RESULTS ON A MALE LIVER TRANSPLANT RECIPIENT PATIENT. THE CUSTOMER ALSO NOTICED DISCREPANCY IN RESULTS BETWEEN HEPARINIZED SAMPLE AND SERUM SAMPLE FROM THE SAME PATIENT. THE FOLLOWING DATA WAS PROVIDED: HEPARINIZED SAMPLE: RESULT = 0.5 S/CO (NONREACTIVE). SERUM SAMPLE: RESULT = 1.1 S/CO, 1.2 S/CO (REACTIVE). HIV1/2 DIFFERENTIATION = NEGATIVE. HIV RNA PCR = NEGATIVE. PREVIOUS RESULT FROM ONE MONTH BEFORE = 0.17 S/CO (NONREACTIVE). THE PATIENT WAS AT THE TOP OF THE LIST FOR LIVER TRANSPLANT AND SURGERY WAS SCHEDULED. SINCE PRETESTING INDICATED A REACTIVE HIV RESULT, SURGERY WAS CANCELLED, AND THE PATIENT DID NOT RECEIVE THE LIVER TRANSPLANT. THE CUSTOMER STATED THE INITIAL TESTING WHICH GENERATED A REACTIVE RESULT WAS PERFORMED BY A NEW LAB TECHNICIAN WHO DID NOT CENTRIFUGE THE SAMPLE AND DID NOT REPEAT TO CONFIRM THE REACTIVE RESULT. HOWEVER, DISCREPANCY BETWEEN SAMPLE TYPES WERE STILL NOTED WITH PROPER HANDLING OF SAMPLES. LIVER TRANSPLANT SURGERY WAS CANCELLED. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15867180 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN EMPLOYEE WHO WAS SPLASHED IN THE EYES WITH ARCHITECT (B)(6) COMBO CONTROLS. THE USER WAS DISPOSING OF USED CONTROLS WHEN THE CONTENTS OF THE CONTROL MATERIAL SPLASHED INTO THE EYES. THE USER WAS NOT WEARING PROTECTIVE EYEWEAR AT THE TIME OF EXPOSURE (A USE ERROR). THE USER IS UNDERGOING EXPOSURE TREATMENT WITH PROPHYLAXIS.

  Patient problems: Chemical Exposure; Eye Injury

  MAUDE report 10837156 ↗
• MalfunctionJan 7, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A (B)(6) ARCHITECT HIV AG/AB COMBO RESULT FOR A KNOWN (B)(6) SAMPLE. THE SAMPLE WAS RETESTED AND GENERATED (B)(6) RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9559360 ↗
• InjuryJul 30, 2018False Positive Result; False Positive Result

  A LITERATURE ARTICLE DIAGNOSTIC ACCURACY OF 4TH GENERATION ARCHITECT HIV AG/AB COMBO ASSAY AND UTILITY OF SIGNAL-TO-CUTOFF RATIO TO PREDICT FALSE POSITIVE HIV TESTS IN PREGNANCY PUBLISHED IN THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY (JUN 15, 2018) BY DRS ADHIKARI, MACIAS, WHITE, ROGERS, MCINTIRE, AND ROBERTS AT THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER IN DALLAS, TEXAS USA REPORTED FALSE REACTIVE ARCHITECT HIV AG/AB COMBO RESULTS WHICH IMPACTED SOME PREGNANT PATIENT AND BABIES. MULTIPLE FALSELY POSITIVE RESULTS WERE OBSERVED WHILE USING ARCHITECT HIV AG/AB COMBO REAGENT FOR PREGNANT PATIENTS. OTHER METHODS WERE HIV NEGATIVE, INCLUDING QUANTITATIVE HIV-1 RNA POLYMERASE CHAIN REACTION (PCR VIRAL LOAD), MULTISPOT HIV-1/HIV-2 RAPID DIFFERENTIATION ASSAY (BIORAD), AND QUALITATIVE RNA ASSAY (HOLOGIC). THE PATIENTS RECEIVED INTERVENTIONS THAT INCLUDED MATERNAL INTRAPARTUM ZIDOVUDINE, NEONATAL ZIDOVUDINE ONLY (PROPHYLAXIS INITIATED), AND NEONATAL ZIDOVUDINE PLUS NEVIRAPINE (PROPHYLAXIS INITIATED). OTHER INTERVENTIONS INCLUDED BREAST-FEEDING DELAYS FOR HIV RESULTS AND NEONATAL HIV TESTING. NO SPECIFIC VALUES PER PATIENT WERE PROVIDE

  Patient problems: No Code Available

  MAUDE report 7731271 ↗