IMMULITE®/IMMULITE® 1000 Systems BRM BR-MA (CA15-3) 10380948Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414963655), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K013984); 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.

• MalfunctionNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIEMENS TECHNICAL OPERATIONS INTERNAL INVESTIGATION HAS IDENTIFIED THAT DISCORDANT FALSELY LOW RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE/ IMMULITE 1000 INSTRUMENT WHEN USING THE BR-MA (CA15-3) ASSAY. THE TWO INVESTIGATIONAL SAMPLES WERE SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE/IMMULITE 1000 INSTRUMENT. THE RESULTS OF THE TWO SAMPLES SPIKED WITH 500 NG/ML OF BIOTIN WERE FALSELY LOW WITH A BIAS OF -71% AND -51% RESPECTIVELY COMPARED TO RESULTS OF THE TWO SAMPLES WITHOUT BIOTIN. THERE WERE NO PATIENT SAMPLES IMPACTED AS THIS WAS FOR INVESTIGATIONAL PURPOSES ONLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041476 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013984. One submission often covers many models, so check the product and lot details in each record.

• Z-1691-2018 · Jan 2, 2018 · Terminated
  IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)
• Z-1677-2018 · Jan 2, 2018 · Terminated
  IMMULITE /IMMULITE 1000 BR-MA (CA15-3)