IMMULITE® 2000 Systems HCG 10381206Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00630414961132), received between Nov 10, 2017 and Sep 16, 2026 — classified as 1 injury, 172 malfunctions.

The most frequently reported specific device problem is “High Test Results” (134 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Feb 22, 2022Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 173 reports, 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 ↗
• 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 ↗
• 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 20238951 ↗
• MalfunctionMar 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INCONSISTENT HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WERE OBTAINED ON TWO DIFFERENT SAMPLES FROM THE SAME PATIENT ON TWO DIFFERENT DAYS ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 HCG REAGENT. THE FIRST SAMPLE FROM THE PATIENT INITIALLY RECOVERED ABOVE THE REFERENCE INTERVAL, BUT THEN RECOVERED LOWER AFTER IT WAS REPEATED THE SAME DAY, USING THE SAME SYSTEM AND REAGENT. THE SECOND SAMPLE FROM THE PATIENT INITIALLY RECOVERED WITHIN THE REFERENCE INTERVAL, BUT THEN RECOVERED HIGHER AFTER IT WAS REPEATED THE SAME DAY, USING THE SAME SYSTEM AND REAGENT. IT IS UNKNOWN WHICH RESULTS WERE CONSIDERED TO BE CORRECT AND WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826314 ↗
• MalfunctionMar 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INCONSISTENT HUMAN CHORIONIC GONADOTROPIN (HCG) RESULTS WERE OBTAINED ON TWO DIFFERENT SAMPLES FROM THE SAME PATIENT ON TWO DIFFERENT DAYS ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 HCG REAGENT. THE FIRST SAMPLE FROM THE PATIENT INITIALLY RECOVERED ABOVE THE REFERENCE INTERVAL, BUT THEN RECOVERED LOWER AFTER IT WAS REPEATED THE SAME DAY, USING THE SAME SYSTEM AND REAGENT. THE SECOND SAMPLE FROM THE PATIENT INITIALLY RECOVERED WITHIN THE REFERENCE INTERVAL, BUT THEN RECOVERED HIGHER AFTER IT WAS REPEATED THE SAME DAY, USING THE SAME SYSTEM AND REAGENT. IT IS UNKNOWN WHICH RESULTS WERE CONSIDERED TO BE CORRECT AND WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826301 ↗
• MalfunctionAug 25, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT ELEVATED PATIENT RESULT FOR A FEMALE PATIENT SAMPLE WHEN RUNNING IMMULITE 2000 XPI, HCG ASSAY LOT 476. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE SAME IMMULITE 2000 XPI INSTRUMENT AND A LOWER RESULT WAS OBTAINED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAY IN DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANT HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622459 ↗
• MalfunctionJan 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED THERE WERE DISCORDANT RESULTS ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI ANALYZER, SERIAL NUMBER (B)(4), USING IMMULITE 2000 HUMAN CHORIONIC GONADOTROPIN (HCG) REAGENT LOT 472. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED TWO MORE TIMES ON THE SAME ANALYZER ON THE SAME DAY. FOR SID (B)(6), THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). FOR SID (B)(6), IT IS NOT KNOWN WHICH REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223550 ↗
• MalfunctionOct 6, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A DISCORDANT ELEVATED PATIENT SAMPLE RESULT ON IMMULITE 2000 HCG ASSAY. WHEN THE SAME SAMPLE AND REDRAWN SAMPLES WERE REMEASURED ON THE SAME IMMULITE INSTRUMENT, THE RESULTS WERE LOWER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. A FROZEN EMBRYO TRANSFER HAS BEEN DELAYED 1 MONTH (1 MENSTRUAL CYCLE) DUE TO THE INCORRECT RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT IMMULITE HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549961 ↗
• MalfunctionOct 1, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED IMMULITE 2000 HCG RESULTS WHICH WERE DISCORDANT RELATIVE TO REPLICATE TESTING. THE CUSTOMER OBTAINED INITIAL IMMULITE 2000 HCG RESULTS FOR TWO PATIENTS WHICH WERE ABOVE THE ASSAY'S 95% REFERENCE RANGE FOR NONPREGNANT FEMALES. REPEAT TESTING USING THE SAME METHOD AND INSTRUMENT PRODUCED LOWER RESULTS, WHICH WAS CONSIDERED DISCORDANT RELATIVE TO CLINICAL EXPECTATION. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525508 ↗
• MalfunctionOct 1, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED IMMULITE 2000 HCG RESULT WHICH WAS DISCORDANT RELATIVE TO REPLICATE TESTING. THE CUSTOMER OBTAINED A DEPRESSED INITIAL IMMULITE 2000 HCG RESULT WHICH WAS CONSIDERED DISCORDANT RELATIVE TO A REPEAT-TEST RESULT OBTAINED USING THE SAME METHOD AND INSTRUMENT. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524954 ↗
• MalfunctionOct 1, 2022High Test Results; High Test Results

  THE CUSTOMER CONTACTED SIEMENS TO REPORT DISCORDANT ELEVATED IMMULITE 2000 XPI HCG RESULTS ON 2 PATIENT SERUM SAMPLES. ON ONE PATIENT, ELEVATED RESULTS WERE OBTAINED COMPARED TO RETEST RESULTS ON ATELLICA IM THCG ON THE SAME DAY AND ON IMMULITE 2000 XPI THAT WERE LOWER ON A DIFFERENT DAY. ON THE OTHER PATIENT, RESULTS WERE ELEVATED COMPARED TO RETEST RESULTS ON ATELLICA IM THCG. THE COMPLAINT INDICATES THAT THE INITIAL DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524899 ↗
• MalfunctionOct 1, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED IMMULITE 2000 HCG RESULT WHICH WAS DISCORDANT RELATIVE TO REPLICATE TESTING. THE CUSTOMER OBTAINED AN INITIAL IMMULITE 2000 HCG RESULT WHICH WAS ABOVE THE ASSAY'S 95% REFERENCE RANGE FOR NONPREGNANT FEMALES. REPEAT TESTING USING THE SAME METHOD AND INSTRUMENT PRODUCED A LOWER RESULT, WHICH WAS CONSIDERED DISCORDANT RELATIVE TO CLINICAL EXPECTATION. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524442 ↗
• MalfunctionOct 1, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF DEPRESSED IMMULITE 2000 HCG RESULTS WHICH WERE DISCORDANT RELATIVE TO REPLICATE TESTING. THE CUSTOMER OBTAINED TWO DEPRESSED INITIAL IMMULITE 2000 HCG RESULTS WHICH WERE CONSIDERED DISCORDANT RELATIVE TO REPEAT-TEST RESULTS OBTAINED USING THE SAME METHOD. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524090 ↗