Access Ferritin 33020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590575052), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.

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.

• InjuryMar 6, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED LOW FERRITIN RESULTS FOR ONE PATIENT SAMPLE. THE RESULT WAS GENERATED ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE INITIAL ELEVATED FERRITIN RESULT WAS RELEASED FROM THE LABORATORY AND THE REPORT WAS SENT TO THE PATIENT. THE PATIENT RECEIVED TREATMENT BASED ON THE INITIAL RESULT ON (B)(6) 2019. THE DETAILS OF THE TREATMENT WERE NOT PROVIDED. THE PATIENT¿S DOSAGE OF MEDICATION WAS ADJUSTED AFTER REPORTING OF THE SECOND LOWER RESULT ON (B)(6) 2019. THE DETAILS OF THE TREATMENT WERE NOT PROVIDED. THE PATIENT WAS SENT FOR EMERGENCY CARE. ON (B)(6) 2019, THE PATIENT WAS DIAGNOSED WITH HEMOPHAGOCYTIC SYNDROME. THE CUSTOMER DID NOT REPORT ANY ADDITIONAL CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC), CALIBRATION AND SYSTEM CHECK WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. INFORMATION ON THE COLLECTION AND PROCESSING OF THE PATIENT SAMPLE IS NOT AVAILABLE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8394289 ↗