IMMULITE 2000 Systems HCGRecalls & reported problems across all models

We found 2 models of IMMULITE 2000 Systems HCG by Siemens Healthcare Diagnostics Products Ltd in the FDA's device registry (GUDID). Together they are named in 189 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2017 and Sep 16, 2026 — classified as 1 injury, 188 malfunctions.

The most frequently reported specific device problem is “High Test Results” (145 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

IMMULITE 2000 Systems HCG recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 22, 2022Open, Classified

   Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

   Z-1015-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported IMMULITE 2000 Systems HCG problems

IMMULITE 2000 Systems HCG models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IMMULITE® 2000 Systems HCG 10381206

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  1 recall173 reports
• IMMULITE® 2000 Systems HCG 10381194

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  1 recall16 reports

Recent IMMULITE 2000 Systems HCG adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Test Results; Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785781 ↗
• MalfunctionSep 16, 2026High Test Results

  The customer reported the observation of discordant HCG results for one patient when using lot 485 on an IMMULITE 2000 XPi instrument. Samples from four different dates were tested and on three of the dates, falsely elevated HCG results were reported to and questioned by the physician(s). Based on the three discordant HCG results, the customer 'focused on ectopic pregnancy'. The result from the fourth date was lower and agreed with testing from an alternate laboratory. In addition, ultrasound images showed no evidence of pregnancy.There are no known reports of patient intervention or adverse health consequences due to this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785776 ↗
• MalfunctionSep 16, 2026High Test Results

  The customer reported the observation of discordant HCG results for one patient when using lot 485 on an IMMULITE 2000 XPi instrument. Samples from four different dates were tested and on three of the dates, falsely elevated HCG results were reported to and questioned by the physician(s). Based on the three discordant HCG results, the customer 'focused on ectopic pregnancy'. The result from the fourth date was lower and agreed with testing from an alternate laboratory. In addition, ultrasound images showed no evidence of pregnancy.There are no known reports of patient intervention or adverse health consequences due to this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785751 ↗
• MalfunctionJul 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF IMPRECISE HCG (HUMAN CHORIONIC GONADOTROPIN) RESULTS OBTAINED ON DILUTED PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT (S/N: (B)(6)). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE PATIENT SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AT OTHER DILUTION FACTORS AND/OR IN MULTIPLE REPLICATES AT THE SAME DILUTION FACTOR. IT IS UNKNOWN WHICH RESULT(S) ARE CORRECT. THE CUSTOMER ENTERED MULTIPLE RESULTS INTO THE PRISCA SYSTEM AND CALCULATED THE RISK OF TRISOMY 21 FOR EACH RESULT, AND THERE WAS NO SIGNIFICANT CHANGE IN THE RISK RATIO. THE PHYSICIAN EVALUATED THE RESULTS WITH THE PATIENT'S CLINICAL INFORMATION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISION HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420031 ↗
• MalfunctionJun 19, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED HCG RESULT WHICH WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT THE NEXT DAY. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT AND THE HIGHER RESULT MATCHED THE RESULT FROM A REFERENCE INSTRUMENT FROM ANOTHER LOCATION. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290005 ↗
• MalfunctionMay 13, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED IMMULITE 2000 HCG RESULT USING LOT 481. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED BASED ON THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS REPEATED ON A NON-SIEMENS INSTRUMENT AND THE LOWER RESULT OBTAINED WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009327 ↗
• MalfunctionFeb 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED HCG RESULT OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED WITH MULTIPLE REPLICATES ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE REPEAT RESULT WHICH WAS CONSIDERED CORRECT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337406 ↗
• MalfunctionFeb 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED HCG RESULT OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED WITH MULTIPLE REPLICATES ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE REPEAT RESULT WHICH WAS CONSIDERED CORRECT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337394 ↗
• MalfunctionFeb 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED HCG RESULT OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED WITH MULTIPLE REPLICATES ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE REPEAT RESULT WHICH WAS CONSIDERED CORRECT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337392 ↗
• MalfunctionFeb 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED HCG RESULT OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED WITH MULTIPLE REPLICATES ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE REPEAT RESULT WHICH WAS CONSIDERED CORRECT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337301 ↗
• MalfunctionDec 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED HCG RESULTS WERE OBTAINED ON A DILUTED PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. HISTORIC RESULTS FOR THE PATIENT WERE < 0.1 MIU/ML. THE SAMPLE WAS REPEATED NEAT AND DILUTED. THE NEAT RESULT WAS LOWER THAN THE INITIAL RESULT AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE REPEAT DILUTED RESULT REMAINED FALSELY ELEVATED AND WAS NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904757 ↗
• MalfunctionDec 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED HCG RESULTS WERE OBTAINED ON A DILUTED PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. HISTORIC RESULTS FOR THE PATIENT WERE < 0.1 MIU/ML. THE SAMPLE WAS REPEATED NEAT AND DILUTED. THE NEAT RESULT WAS LOWER THAN THE INITIAL RESULT AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE REPEAT DILUTED RESULT REMAINED FALSELY ELEVATED AND WAS NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904527 ↗
• MalfunctionOct 30, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED HCG RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED, UNDILUTED, AND WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULT WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). BASED ON THE FALSELY ELEVATED HCG RESULTS, AN IN VITRO FERTILIZATION (IVF) PROCEDURE WAS WITHHELD. HOWEVER, THERE ARE NO REPORTS OR ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569144 ↗
• MalfunctionSep 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT HCG RESULTS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. ONE OF THE REPEAT RESULTS WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238979 ↗
• MalfunctionSep 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT HCG RESULTS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE NOT REPORTED. IT IS UNKNOWN WHICH RESULT IS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238968 ↗

Other Siemens Healthcare Diagnostics Products Ltd products

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