IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 10380900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414964874), received between Jan 4, 2019 and Jan 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K971177); they may or may not involve this specific model.

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 18, 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.

• MalfunctionJan 4, 2019Leak/Splash; Leak/Splash

  SIEMENS WAS INFORMED THAT WHILE USING THE VITAMIN B12 BORATE KCN BUFFER SOLUTION, 20-30 ML OF THE BUFFER SPILLED ON THE OPERATOR'S LEGS. THE OPERATOR'S SKIN WAS RED AT THE SITE OF THE BUFFER CONTACT AREA BUT FADED AFTER A SHORT PERIOD OF TIME. THE CUSTOMER INFORMED SIEMENS THAT THE OPERATOR WAS WEARING GLOVES AT THE TIME OF USE. THE OPERATOR CONSULTED A PHYSICIAN(S). IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS RENDERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SPILL OF THE BUFFER SOLUTION ON THE OPERATOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8217112 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K971177. One submission often covers many models, so check the product and lot details in each record.

• Z-1686-2018 · Jan 2, 2018 · Terminated
  IMMULITE /IMMULITE 1000 Vitamin B12