IMMULITE® 2000 Systems CAL Calcitonin 10381446Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414961156), received between Jan 8, 2018 and Nov 26, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K023304); 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.

• MalfunctionNov 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF CALIBRATION AND REPRODUCIBILITY ISSUES ON PATIENT RESULTS WITH CALCITONIN (CAL), LOT 340 ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6). THE PATIENT RESULTS PROVIDED TO SIEMENS WERE NOT REPORTED TO THE PHYSICIAN AS IT IS UNKNOWN WHICH RESULT IS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779070 ↗
• MalfunctionMay 17, 2024Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED IMPRECISE CALCITONIN RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE XPI INSTRUMENT. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER AND ON AN ALTERNATE IMMULITE 2000 XPI AND THE TRUE RESULT OF BOTH SAMPLES WAS DETERMINED TO BE 10.5 PG/ML. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE CALCITONIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341873 ↗
• MalfunctionSep 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCORDANT PATIENT SAMPLE RESULTS WHEN USING IMMULITE 2000 XPI CALCITONIN (CAL) LOT 325, IN COMPARISON TO REPEAT RESULTS. RESULTS FOR THIS SAMPLE WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE 2000 XPI CALCITONIN (CAL) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393421 ↗
• MalfunctionApr 5, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DEPRESSED IMMULITE 2000 XPI CALCITONIN RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT UPON COMPARISON WITH REPEAT RESULTS FROM AN ALTERNATE PLATFORM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED IMMULITE 2000 XPI CALCITONIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014476 ↗
• MalfunctionApr 5, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DEPRESSED IMMULITE 2000 XPI CALCITONIN RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT UPON COMPARISON WITH REPEAT RESULTS FROM AN ALTERNATE PLATFORM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED IMMULITE 2000 XPI CALCITONIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014475 ↗
• MalfunctionNov 15, 2019Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY DEPRESSED CALCITONIN (CAL) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING ANOTHER IMMULITE 2000 XPI. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CAL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9331230 ↗
• MalfunctionJun 21, 2019Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY DEPRESSED CALCITONIN (CAL) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). ONE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI AND WAS DISCORDANT. ALL FOUR SAMPLES WERE REPEATED USING SIEMENS ADVIA CENTAUR AND THE NEW RESULTS WERE CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CAL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724316 ↗
• MalfunctionJun 21, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED CALCITONIN (CAL) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING SIEMENS ADVIA CENTAUR AND THE NEW RESULT WAS CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CAL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8724311 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED CALCITONIN RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE UPON INITIAL AND REPEAT TESTING ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING REAGENT LOT 267. ACCORDING TO THE CUSTOMER: THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S); THE PHYSICIAN(S) PERFORMED AN UNSPECIFIED SURGERY ON THE PATIENT; AND THE PHYSICIAN(S) QUESTIONED THE RESULT OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT AS THE ELEVATED CALCITONIN RESULT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT OBSERVED AFTER SURGERY. THE CUSTOMER REPORTED THAT: IT TESTED THE SAMPLE TWICE ON AN ALTERNATE PLATFORM (RADIOIMMUNOASSAY (RIA) CALCITONIN METHOD); THE RESULTS FROM THE ALTERNATE PLATFORM WERE LOWER THAN THE RESULTS OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT; FOR TROUBLESHOOTING PURPOSES, IT PERFORMED TESTING WITH HETEROPHILIC BLOCKING TUBES (HBT); THESE TESTS ALSO HAD RESULTS THAT WERE LOWER THAN THE INITIAL AND REPEAT RESULTS OBTAINED ON THE IMMULITE 2000 XPI INSTRUMENT; AND THE CORRECTED RESULT FROM THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). OTHER THAN THE ALLEGED UNSPECIFIED SURGERY, THERE HAVE BEEN NO REPORTS OF IMPACT TO THE PATIENT OR ADVERSE

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7171346 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023304. One submission often covers many models, so check the product and lot details in each record.

• Z-0212-2015 · Oct 20, 2014 · Terminated
  IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE Systems Analyzers for the quantitative me