Synchron 471288Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15099590233402), received between Jan 26, 2018 and Sep 20, 2018 — classified as 2 malfunctions.

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

• MalfunctionSep 20, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY LOW SODIUM (NA) RESULTS ON THEIR UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RECOVERED WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THERE WAS NO CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896408 ↗
• MalfunctionJan 26, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED ERRONEOUSLY LOW NA (SODIUM) PATIENT RESULTS WERE GENERATED ON THEIR UNICEL DXC 600 PRO SYNCHRON SYSTEM USING AQUA CALIBRATOR LEVEL LOT 72853811. THE CUSTOMER STATED THE PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER THE RESULTS WERE AMENDED/CORRECTED WITH NO CHANGE TO PATIENT TREATMENT. A REVIEW OF THE CUSTOMER PROVIDED DATA CONFIRMS THE INSTRUMENT GENERATED 1 (ONE) ERRONEOUSLY LOW NA PATIENT RESULT. A REVIEW OF THE NA QUALITY CONTROL (QC) DATA PROVIDED SHOWS RECOVERIES FOR LEVEL 2 WERE GREATER THAN 2SD LOW OF THE INSTRUMENT CONTROL MEAN ON THE EVENT DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7222202 ↗