ARCHITECT 7D63-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740161699), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATINE KINASE RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS FROM ONE PATIENT WERE PROVIDED: SID (B)(6). INITIAL RUN (ERROR CODE 1350 ¿UNABLE TO CALCULATE RESULT NO ABSORBANCE READS WITHIN ABSORBANCE RANGE¿). DILUTION: 1:2, NO RESULT EC1350. RESULTS WERE GENERATED WITH DILUTED SAMPLE (1:10): <70 U/L. REPEAT RUN ON SN (B)(6). (ERROR CODE 1350 ¿UNABLE TO CALCULATE RESULT NO ABSORBANCE READS WITHIN ABSORBANCE RANGE¿), DILUTION:1:2, NO RESULT, EC 1350. DILUTION:1:10, RESULT >42670 U/L. SID (B)(6). INITIAL RUN (ERROR CODE 1350 ¿UNABLE TO CALCULATE RESULT NO ABSORBANCE READS WITHIN ABSORBANCE RANGE¿) DILUTED SPECIMEN 1:2, NO RESULT EC 1350. DILUTED SPECIMEN 1:10; RESULT:<70 U/L. REPEAT RUN ON SN (B)(6). (ERROR CODE 1350 ¿UNABLE TO CALCULATE RESULT NO ABSORBANCE READS WITHIN ABSORBANCE RANGE¿), DILUTION:1:2, NO RESULT EC 1350, DILUTION:1:10, RESULT >42670. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156592 ↗