EXACTAMIX EXACTA24-DYRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412609034), received between Apr 6, 2021 and Jul 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LIPIDS WERE LEAKING FROM PORT 2 OF AN AUTOMATED COMPOUNDING DEVICE INTO THE FINAL BAG. CLINILIPID WAS ON PORT 1 AND SMOFLIPID WAS ON PORT 2 DURING COMPOUNDING AT THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981320 ↗
• MalfunctionApr 6, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE DISPLAY OF AN EXACTAMIX AUTOMATED COMPOUNDING DEVICE WAS CONTAMINATED WITH A MICROBIAL GROWTH. THE CONTAMINATION WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619501 ↗