IMMULITE® 2000 Systems BRM BR-MA (CA15-3) 10380983Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414961088), received between Nov 17, 2017 and Oct 4, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023High Test Results; High Test Results

  A FALSELY ELEVATED BR-MA (CA15-3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLE WAS REPEATED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BR-MA (CA15-3) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872556 ↗
• MalfunctionFeb 10, 2022High Test Results; High Test Results

  A CUSTOMER OBTAINED AN ELEVATED IMMULITE 2000 XPI BR-MA (CA15-3) RESULT ON A PATIENT SAMPLE (ABOVE REFERENCE RANGE RESULT). THE RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS SENT TO ANOTHER SITE AND WAS RETESTED WITH AN ALTERNATE METHOD AND A LOWER RESULT WAS OBTAINED (WITHIN REFERENCE RANGE RESULT). THE INITIAL ELEVATED RESULT WAS CONSIDERED DISCORDANT COMPARED TO THE ALTERNATE TEST METHOD RESULT. THE SAMPLE WAS SENT BACK TO THE CUSTOMER SITE AND WAS RETESTED ON THE SAME IMMULITE 2000 XPI INSTRUMENT. AN ELEVATED RESULT WAS OBTAINED (ABOVE REFERENCE RANGE RESULT). THE RESULT FROM THE ALTERNATE METHOD WAS CONSIDERED TO BE CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CA15-3 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505500 ↗
• MalfunctionFeb 10, 2022High Test Results; High Test Results

  A CUSTOMER OBTAINED AN ELEVATED IMMULITE 2000 XPI BR-MA (CA15-3) RESULT ON A PATIENT SAMPLE (ABOVE REFERENCE RANGE RESULT). THE RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS SENT TO ANOTHER SITE AND WAS RETESTED WITH AN ALTERNATE METHOD AND A LOWER RESULT WAS OBTAINED (WITHIN REFERENCE RANGE RESULT). THE INITIAL ELEVATED RESULT WAS CONSIDERED DISCORDANT COMPARED TO THE ALTERNATE TEST METHOD RESULT. THE SAMPLE WAS SENT BACK TO THE CUSTOMER SITE AND WAS RETESTED ON THE SAME IMMULITE 2000 XPI INSTRUMENT. AN ELEVATED RESULT WAS OBTAINED (ABOVE REFERENCE RANGE RESULT). THE RESULT FROM THE ALTERNATE METHOD WAS CONSIDERED TO BE CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CA15-3 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505499 ↗
• MalfunctionAug 12, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A DISCORDANT, ELEVATED RESULT ON A PATIENT SAMPLE USING THE IMMULITE 2000 XPI BR-MA (CA15-3) ASSAY AND QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WHEN REPEATED WAS ELEVATED. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE CA15-3 TEST METHOD, RESULTING LOWER. THE LOWER CA15-3 RESULT AGREED WITH THE PATIENT'S CLINICAL PICTURE AND WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BR-MA (CA15-3) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315688 ↗
• MalfunctionDec 14, 2017Nonstandard Device; Adverse 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 HIGH RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE 2000/ IMMULITE 2000 XPI INSTRUMENT WHEN USING THE CARCINOEMBRYONIC (CEA) ASSAY. THE INVESTIGATIONAL SAMPLE WAS SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS, AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE 2000/IMMULITE 2000 XPI INSTRUMENT. THE RESULT OF THE SAMPLE SPIKED WITH 1200 NG/ML OF BIOTIN WERE FALSELY HIGH WITH A BIAS OF +31% COMPARED TO THE RESULT OF THE SAMPLE 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 7118364 ↗
• MalfunctionDec 14, 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 2000/ IMMULITE 2000 XPI INSTRUMENT WHEN USING THE 3G ALLERGEN SPECIFIC IGE ASSAY. FIVE SPECIFIC ALLERGENS WERE USED FOR THE TESTING - OLIVE SPECIFIC ALLERGEN, CAT DANDER, LATEX ALLERGEN, WHEAT ALLERGEN, AND CHIRONOMUS SPP ALLERGEN. THE TWO INVESTIGATIONAL SAMPLES WERE SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS, FOR EACH SPECIFIC ALLERGEN AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE 2000/IMMULITE 2000 XPI INSTRUMENT. A GREATER THAN ONE CLASS CHANGE (FALSELY LOW) IN RESULT WAS OBSERVED AT BIOTIN CONCENTRATIONS OF 250 NG/ML WITH OLIVE ALLERGEN, 100 NG WITH CAT DANDER ALLERGEN, 75 NG/ML WITH LATEX ALLERGEN, 250 NG/ML WITH WHEAT ALLERGEN AND 75 NG/ML OF CHIRONOMUS SPP ALLERGEN 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 7118357 ↗
• MalfunctionDec 14, 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 HIGH RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE 2000/ IMMULITE 2000 XPI INSTRUMENT WHEN USING THE OM-MA (CA 125) ASSAY. TWO INVESTIGATIONAL SAMPLES WERE SPIKED WITH BIOTIN AT MULTIPLE CONCENTRATIONS, AND RUN FOR INVESTIGATIONAL PURPOSES ON AN IMMULITE 2000/IMMULITE 2000 XPI INSTRUMENT. THE RESULTS OF THE TWO SAMPLES SPIKED WITH 75 NG/ML AND 250 NG/ML OF BIOTIN WERE FALSELY HIGH WITH A BIAS OF +41% AND +38% 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 7118353 ↗
• MalfunctionDec 14, 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 HIGH RESULTS WERE OBTAINED ON TWO INVESTIGATIONAL SAMPLES ON AN IMMULITE/ IMMULITE 1000 INSTRUMENT WHEN USING THE OM-MA (CA 125) ASSAY. 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 75 NG/ML OF BIOTIN WERE FALSELY HIGH WITH A BIAS OF +45% AND +38% 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 7118352 ↗
• 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 2000/ IMMULITE 2000 XPI 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 2000/IMMULITE 2000 XPI INSTRUMENT. THE RESULTS OF THE TWO SAMPLES SPIKED WITH 500 NG/ML OF BIOTIN WERE FALSELY LOW WITH A BIAS OF -73% AND -53% 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 7041463 ↗

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