ARCHITECT 06R8630Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740192150), received between Jun 12, 2020 and Sep 9, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE SARS-COV-2 IGG RESULTS FOR AN (B)(6) YEAR-OLD FEMALE, WHO TESTED POSITIVE BY COVID-19 PCR TESTING ON (B)(6) 2020. THE FOLLOWING DATA WAS PROVIDED (<1.4 INDEX (S/C) IS NEGATIVE, >/=1.4 INDEX (S/C) IS POSITIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 0.78 INDEX (S/C), REPEAT WAS 0.78 INDEX (S/C). THE SAMPLE WAS THEN REPEATED USING BECKMAN COULTER SARS-COV-2 IGG TESTING AND THE RESULT WAS 1.65 S/CO, >/= 1.00 S/CO IS POSITIVE. THE SAMPLE WAS ALSO TESTED BY THE CUSTOMER'S IMMUNOLOGY DEPARTMENT USING LATERAL FLOW TESTING, WHICH TESTS FOR IGM AND IGG, AND WAS IGG POSITIVE. IT WAS NOTED THAT THE PATIENT WAS NEGATIVE FOR COVID-19 PCR TESTING ON (B)(6) 2020. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10508787 ↗
• MalfunctionJun 26, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT SARS-COV-2 IGG ON A (B)(6) YR OLD ASYMPTOMATIC WHITE MALE PATIENT. RESULTS PROVIDED: ON (B)(6) 2020 SID (B)(6) = 4.13 / 4.09 INDEX (> OR = 1.4 INDEX IS POSITIVE), SAME SAMPLE RUN ON (B)(6) 2020 BY HAMA = 4.03 S/CO; NEW SAMPLE ON (B)(6) 2020 SID (B)(6) = 4.02 INDEX; ON (B)(6) 2020 ON BECKMAN ACCESS = 0.01 S/CO (NEGATIVE), EDI NOVEL CORONAVIRUS COVID-19 IGG ELISA = 0.17 OD (NEGATIVE). ADDITIONAL ASYMPTOMATIC PATIENT SID (B)(6) = 2.29 / 2.23 INDEX, BECKMAN ACCESS = 0.02 S/CO (NEGATIVE), ELIZA EDA = 0.160 O/D (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10202415 ↗
• MalfunctionJun 12, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULTS ON ONE (B)(6) YEAR OLD PATIENT WHILE PERFORMING CORRELATION STUDIES WITH BIOMEDOMICS COVID19 IGM-IGG RAPID TEST. THE RESULTS GENERATED WERE BEING USED FOR INDIVIDUAL PATIENT MANAGEMENT. THE SAMPLE WAS COLLECTED AT A DRIVE THROUGH TESTING SITE, THEREFORE, NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. THE RESULTS PROVIDED WERE: ON (B)(6) ARCHITECT = 0.03S/C (<1.4S/C = NEGATIVE) / RETESTED = 0.02 AND 0.03S/C; BIOMEDOMICS TEST SHOWS A STRONG POSITIVE IGG BAND. THE SAMPLE WAS ALSO TESTED ON SYNTRON IGG / IGM AND WAS POSITIVE FOR IGG. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10147775 ↗