ARCHITECT 7K78-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740106003), received between Sep 22, 2017 and Jan 2, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2018False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT IMPRECISE ARCHITECT TOTAL B-HCG RESULTS WERE GENERATED. PATIENT 2: 29 MIU/ML (B)(6) AND LESS THAN 5 MIU/ML (B)(6) TWICE. THE RESULT OF 29 MIU/ML IS SUSPECTED TO BE FALSELY (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7157031 ↗
• MalfunctionDec 7, 2017False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSELY ELEVATED B-HCG RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 724.61 MIU/ML, REPEAT < 1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7096480 ↗
• MalfunctionOct 3, 2017False Positive Result; False Positive Result

  THE ACCOUNT GENERATED FALSE POSITIVE ARCHITECT BHCG ON A PATIENT THAT DID NOT MATCH THE CLINICAL HISTORY. ON (B)(6) 2017, ID 7672024 GENERATED ARCHITECT BHCG POSITIVE OF 203.8 AND 173.23 (NO UNIT OF MEASUREMENT WAS PROVIDED). A FEW DAYS LATER THE SAME SAMPLE WAS TESTED AGAIN WITH THE SAME POSITIVE ARCHITECT BHCG RESULTS (200 AND 173). ON (B)(6) 2017 NEW SAMPLES WERE OBTAINED AND TESTED ARCHITECT BHCG NEGATIVE (<1.2 AND <1.2). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6911316 ↗
• MalfunctionSep 22, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT B-HCG RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID2336194 - INITIAL = 246.61 MIU/ML/ REPEAT = <1.2 / REPEAT 2X BOTH WERE NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886877 ↗