Synchron 476861Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590625597), received between Mar 2, 2017 and Dec 19, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED RECEIVING ERRONEOUS LOW PATIENT RESULTS FOR TOTAL BILIRUBIN (TBIL) ON THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182708 ↗
• MalfunctionMar 2, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER STATED ERRONEOUS DBIL (DIRECT BILIRUBIN) AND TBIL (TOTAL BILIRUBIN) PATIENT RESULTS WERE GENERATED ON THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THE PATIENT SAMPLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO IMPACT TO PATIENT TREATMENT. THE TBIL AND DBIL QUALITY CONTROL (QC) RECOVERIES WERE WITHIN INSTRUMENT CONTROL RECOVERIES DURING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375163 ↗