IMMULITE® 2000 XPi Immunoassay System 10373214Recalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 00630414945422), received between Jun 21, 2017 and May 7, 2026 — classified as 1 injury, 285 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (66 reports).

13 other recalls cover devices cleared under the same FDA submission (K970227); 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 25 most recent of 286 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Low Readings

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT CALCITONIN (CAL) RESULTS THAT WERE OBTAINED ON ONE PATIENT SAMPLE USING TWO DIFFERENT INSTRUMENTS OF IMMULITE 2000 XPI. THE REPEAT TESTING WAS CONSIDERED CORRECT. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN. IT IS UNKNOWN IF THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111845 ↗
• MalfunctionMar 11, 2026Smoking

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THE OBSERVATION OF SMOKE, SMELL OF SMOKE FOR THE IMMULITE 2000XPI, SERIAL NUMBER (B)(6). THERE WERE NO REPORTS OF INJURIES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566998 ↗
• MalfunctionJan 9, 2026Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED CALCITONIN RESULTS OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. ONE SAMPLE WAS REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT; ONE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE NOT RECTIFIED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CALCITONIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027698 ↗
• MalfunctionNov 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT WITH MULTIPLE ASSAYS: CEA (CARCINOEMBRYONIC ANTIGEN) AND PSA (PROSTATE-SPECIFIC ANTIGEN). THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE 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 CEA AND PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497841 ↗
• MalfunctionNov 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT WITH MULTIPLE ASSAYS: CEA (CARCINOEMBRYONIC ANTIGEN) AND PSA (PROSTATE-SPECIFIC ANTIGEN). THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE 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 CEA AND PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497840 ↗
• MalfunctionSep 17, 2025Smoking; Smoking

  THE CUSTOMER REPORTED THAT WHEN PROCESSING SAMPLES, THE IMMULITE 2000 XPI INSTRUMENT SERIAL NUMBER (B)(6) DISPLAYED THE FOLLOWING SAMPLE VALVE JAM ERRORS: - 281 - SAMPLE VALVE HAS JAMMED WHILE HOMING. - 579 - CORRECTIVE JAM ACTIONS HAS ALSO JAMMED GOING INTO PAUSE MODE. - 581 - HOMING SAMPLE DEVICES RESULTED IN A JAM RETURNING TO PAUSE MODE. PRIOR TO CONTACTING TECHNICAL SUPPORT FOR ASSISTANCE, THE CUSTOMER ATTEMPTED TO HOME ALL MOTORS IN DIAGNOSTICS, AND REPORTED HEARING A "POP" AND OBSERVING A PUFF OF SMOKE FROM THE SAMPLE VALVE AREA. CUSTOMER REPORTED A BRIEF BURNING SMELL. THERE WAS NO IMPACT TO PATIENT RESULTS. THERE WERE NO FLAMES OBSERVED. THE BURNING SMELL WAS TEMPORARY. THERE WERE NO INJURIES OR EXPOSURE TO A POTENTIALLY DANGEROUS CHEMICAL OR HAZARDOUS MATERIAL DUE TO THE PUFF OF SMOKE. THE FIRE DEPARTMENT WAS NOT CALLED. THE LAB WAS NOT EVACUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076398 ↗
• MalfunctionJun 6, 2025Sparking; Sparking

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT THE SPINNER WASTE LINE OF THEIR IMMULITE 2000 XPI SYSTEM WAS CLOGGED AND OVERFLOWED. THE POWER SUPPLY SPARKED DUE TO DRIPPED WASTE LIQUID. THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WORE PERSONAL PROTECTIVE EQUIPMENT WHEN CLEANING THE SPILL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159231 ↗
• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED UNCONJUGATED ESTRIOL RESULT FOR ONE PATIENT SAMPLE USING KIT LOT 518 ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO BUT NOT QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT AND THE REPEAT RESULT, WHICH WAS HIGHER THAN THE INITIAL 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 UNCONJUGATED ESTRIOL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124190 ↗
• MalfunctionSep 30, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY DEPRESSED VETERINARY PATIENT RESULTS WITH PHENOBARBITAL (PHEN), LOT 327 ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6). THE FALSELY DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS AND WERE QUESTIONED. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL INSTRUMENT, OR ON THE CUSTOMER'S ALTERNATE INSTRUMENT AND ONE SAMPLE WAS SENT TO AN ALTERNATE LAB, INSTRUMENT IS UNKNOWN. ALL REPROCESSED SAMPLES RECOVERED HIGHER. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER INDICATED THE ISSUE STARTED ON (B)(6) 2024 AND POTENTIALLY THERE HAVE BEEN APPROXIMATELY 20 OCCURRENCES OF DISCREPANCIES WITH VETERINARY PATIENT SAMPLES, HOWEVER. THE CUSTOMER PROVIDED RESULTS FROM THREE SAMPLES TESTED ON (B)(6) 2024. THE CUSTOMER ALSO STATED THE ISSUE IS OCCURRING WITH QUALITY CONTROL (QC). THE QC FOR THIS ASSAY WOULD RESULT AS "" AND THEN REPEATED WITH THE SAME CONTROL MATERIAL AND WOULD THEN BE IN RANGE. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20335836 ↗
• MalfunctionAug 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT DEPRESSED IGF-I (IGF) RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043099 ↗
• MalfunctionAug 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ERRONEOUS TROPONIN I (TPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI SYSTEM. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE INITIAL RESULT. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT, THEREFORE A CORRECTED REPORT HAS NOT BEEN ISSUED. DURING THE PERIOD WHEN THE CUSTOMER WAS NOT REPORTING IMMULITE 2000 TROPONIN I PATIENT RESULTS ON THIS INSTRUMENT, THERE WAS BACKUP TESTING AVAILABLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS TROPONIN I RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029691 ↗
• MalfunctionAug 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT TROPONIN I (TPI) RESULTS OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT (S/N: (B)(6)). IT IS UNKNOWN IF THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). IF REPORTED, THE PHYSICIAN(S) DID NOT QUESTION THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE CUSTOMER DOES NOT KNOW WHICH RESULTS ARE CORRECT, THEREFORE A CORRECTED REPORT HAS NOT BEEN ISSUED. THE CUSTOMER STOPPED REPORTING TROPONIN I RESULTS SINCE THEY NOTICED THE ISSUE ON 24-JUL-2024. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN I RESULTS. DURING THE PERIOD WHEN THE CUSTOMER WAS NOT REPORTING IMMULITE 2000 TROPONIN I PATIENT RESULTS ON THIS INSTRUMENT, THERE WAS BACKUP TESTING AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971161 ↗
• MalfunctionJul 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY LOW ALLERGEN SPECIFIC IGE RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 XPI SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). DEPENDING ON THE SAMPLE, THE SAMPLE WAS RERUN FOR ALLERGEN SPECIFIC IGE ON AN ALTERNATE SYSTEM EITHER ONE, TWO, OR THREE DAYS AFTER THE INITIAL SAMPLE WAS RUN, AND THE RESULTS RECOVERED HIGHER. ONE OF THE SAMPLES WAS RUN AGAIN FOR ALLERGEN SPECIFIC IGE THREE DAYS LATER ON A SECOND ALTERNATE SYSTEM, CONFIRMING THE HIGHER RESULTS. A CORRECTED REPORT WAS ONLY ISSUED FOR THE SAMPLE WHICH HAD BEEN REPEATED TWICE, IN WHICH CASE THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW ALLERGEN SPECIFIC IGE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795211 ↗
• MalfunctionJul 5, 2024Low Test Results; Low Test Results

  A CUSTOMER REPORTED THAT A FALSELY LOW CALCITONIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI SYSTEM. IT IS UNKNOWN IF THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR CALCITONIN THREE DAYS LATER AND THE RESULT RECOVERED HIGHER. THE HIGHER 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 LOW CALCITONIN RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683345 ↗
• MalfunctionJul 5, 2024Low Test Results; Low Test Results

  A CUSTOMER REPORTED THAT TWO FALSELY LOW INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI SYSTEM. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR IGF-1 FOUR DAYS LATER AND THE RESULTS RECOVERED HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW IGF-1 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683318 ↗
• MalfunctionJun 7, 2024Fire; Fire

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT THE TRANSFORMER OF THE CUSTOMER¿S IMMULITE 2000 XPI SYSTEM HAD CAUGHT FIRE AND MELTED WIRES. IT IS UNKNOWN IF THERE WERE VISIBLE SMOKE OR FLAMES AS THE CUSTOMER WAS NOT IN LABORATORY WHEN THE EVENT HAPPENED. NO BURNING SMELL WAS NOTED BUT THE SYSTEM WAS DOWN DUE TO THE ISSUE. THERE WAS NO DELAY IN TESTING AS THE CUSTOMER HAD BACKUP SYSTEMS TO PROCESS SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485081 ↗
• MalfunctionMay 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT ERRONEOUS, FALSELY LOW INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON AN IMMULITE 2000 XPI SYSTEM (S/N: O6230). THE SAMPLES WERE REPEATED FOR IGF-1 ON AN ALTERNATE IMMULITE 2000 XPI SYSTEM. THE REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS IGF-1 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279914 ↗
• MalfunctionMay 9, 2024Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT ERRONEOUS, FALSELY LOW INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON AN IMMULITE 2000 XPI SYSTEM (S/N: O6230). THE SAMPLES WERE REPEATED FOR IGF-1 ON AN ALTERNATE IMMULITE 2000 XPI SYSTEM. THE REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS IGF-1 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279827 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  A PATIENT SAMPLE WAS RUN FOR TOXOPLASMA IGG (TOXOG) TWO TIMES ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE® 2000 TOXOPLASMA QUANTITATIVE IGG REAGENT. ONE RESULT RECOVERED REACTIVE AND ONE RESULT RECOVERED NON-REACTIVE. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED 3 TIMES ON THE SAME ANALYZER AND PRODUCED THREE REACTIVE RESULTS. THE SAMPLE WAS THEN REPEATED 4 TIMES ON AN ALTERNATE IMMULITE 2000 XPI AT A DIFFERENT LABORATORY AND THE RESULTS WERE NON-REACTIVE. THE SAMPLE WAS ALSO REPEATED ON AN ATELLICA IM AND THE RESULT WAS NON-REACTIVE. THE NON-REACTIVE RESULTS WERE REPORTED AND CONSIDERED CORRECT. ANOTHER PATIENT SAMPLE FROM A DIFFERENT PATIENT WAS RUN FOR TOXOG ON IMMULITE 2000 XPI SYSTEM (SERIAL NUMBER: (B)(6)) THREE TIMES, RECOVERING REACTIVE. THE SAMPLE WAS THEN RUN FOR TOXOG ON AN ATELLICA IM AND RECOVERED NON-REACTIVE. THE NON-REACTIVE RESULT WAS CONSIDERED CORRECT AND WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY REACTIVE TOXOG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999181 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  A PATIENT SAMPLE WAS RUN FOR TOXOPLASMA IGG (TOXOG) TWO TIMES ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE® 2000 TOXOPLASMA QUANTITATIVE IGG REAGENT. ONE RESULT RECOVERED REACTIVE AND ONE RESULT RECOVERED NON-REACTIVE. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED 3 TIMES ON THE SAME ANALYZER AND PRODUCED THREE REACTIVE RESULTS. THE SAMPLE WAS THEN REPEATED 4 TIMES ON AN ALTERNATE IMMULITE 2000 XPI AT A DIFFERENT LABORATORY AND THE RESULTS WERE NON-REACTIVE. THE SAMPLE WAS ALSO REPEATED ON AN ATELLICA IM AND THE RESULT WAS NON-REACTIVE. THE NON-REACTIVE RESULTS WERE REPORTED AND CONSIDERED CORRECT. ANOTHER PATIENT SAMPLE FROM A DIFFERENT PATIENT WAS RUN FOR TOXOG ON IMMULITE 2000 XPI SYSTEM (SERIAL NUMBER: (B)(6)) THREE TIMES, RECOVERING REACTIVE. THE SAMPLE WAS THEN RUN FOR TOXOG ON AN ATELLICA IM AND RECOVERED NON-REACTIVE. THE NON-REACTIVE RESULT WAS CONSIDERED CORRECT AND WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY REACTIVE TOXOG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999099 ↗
• MalfunctionMar 28, 2024False Positive Result; False Positive Result

  A PATIENT SAMPLE WAS RUN FOR TOXOPLASMA IGG (TOXOG) TWO TIMES ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE® 2000 TOXOPLASMA QUANTITATIVE IGG REAGENT. ONE RESULT RECOVERED REACTIVE AND ONE RESULT RECOVERED NON-REACTIVE. THE FOLLOWING DAY, THE SAME SAMPLE WAS REPEATED 3 TIMES ON THE SAME ANALYZER AND PRODUCED THREE REACTIVE RESULTS. THE SAMPLE WAS THEN REPEATED 4 TIMES ON AN ALTERNATE IMMULITE 2000 XPI AT A DIFFERENT LABORATORY AND THE RESULTS WERE NON-REACTIVE. THE SAMPLE WAS ALSO REPEATED ON AN ATELLICA IM AND THE RESULT WAS NON-REACTIVE. THE NON-REACTIVE RESULTS WERE REPORTED AND CONSIDERED CORRECT. ANOTHER PATIENT SAMPLE FROM A DIFFERENT PATIENT WAS RUN FOR TOXOG ON IMMULITE 2000 XPI SYSTEM (SERIAL NUMBER: (B)(6) THREE TIMES, RECOVERING REACTIVE. THE SAMPLE WAS THEN RUN FOR TOXOG ON AN ATELLICA IM AND RECOVERED NON-REACTIVE. THE NON-REACTIVE RESULT WAS CONSIDERED CORRECT AND WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY REACTIVE TOXOG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998881 ↗
• MalfunctionMar 22, 2024Low Test Results; Low Test Results

  FALSELY DEPRESSED INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 (IGFB-3) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 (IGFB-3) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958072 ↗
• MalfunctionDec 4, 2023High Test Results; High Test Results

  ERRONEOUS, FALSELY ELEVATED FREE PROSTATE SPECIFIC ANTIGEN (FPSA) AND TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 XPI SYSTEM. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAMPLES THAT HAD RECOVERED FALSELY ELEVATED AND REPORTED THE REPEAT RESULTS, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259055 ↗
• MalfunctionDec 1, 2023Low Test Results; Low Test Results

  ERRONEOUS, FALSELY LOW INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 XPI SYSTEM (SERIAL NUMBER: (B)(6) . THE FALSELY LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). WHEN REPEATED, THE SAMPLES RECOVERED HIGHER FOR IGF-1. THE HIGHER RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW IGF-1 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247020 ↗
• MalfunctionDec 1, 2023Low Test Results; Low Test Results

  FOLLOWING THE OBSERVATION OF OUT-OF-RANGE QUALITY CONTROL (QC) RESULTS WITH THE IGF-I ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT, PREVIOUSLY TESTED PATIENT SAMPLES WERE REVIEWED. FALSELY DEPRESSED IGF-I RESULTS WERE OBSERVED WITH 10 PATIENT SAMPLES. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). WHEN THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT IN THE CUSTOMER¿S LAB, THE REPEAT RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED IGF-I RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246664 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970227. One submission often covers many models, so check the product and lot details in each record.

• Z-2469-2020 · May 15, 2020 · Terminated
  Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
• Z-2470-2020 · May 15, 2020 · Terminated
  Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
• Z-1658-2015 · Mar 5, 2015 · Terminated
  Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instr
• Z-1660-2015 · Mar 5, 2015 · Terminated
  Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instrume
• Z-1662-2015 · Mar 5, 2015 · Terminated
  Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use se
• Z-1661-2015 · Mar 5, 2015 · Terminated
  Direct Water feed Kit, Catalog#10373222
• Z-1663-2015 · Mar 5, 2015 · Terminated
  Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instru
• Z-1832-2014 · Apr 25, 2014 · Terminated
  VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes sam
• Z-1316-2014 · Feb 3, 2014 · Terminated
  IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use ser
• Z-1033-2010 · Oct 21, 2009 · Terminated
  IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
• Z-1891-2010 · May 15, 2009 · Terminated
  IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
• Z-1399-2009 · Jan 5, 2009 · Terminated
  Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnosti
• Z-0994-05 · Apr 22, 2005 · Terminated
  IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836