IMMULITE® 2000 Systems IPT Intact PTH 10381441Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00630414961910), received between Jun 29, 2017 and Jan 13, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K013566); 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.

Recalls naming this device

1. Sep 22, 2025Class IIOpen, Classified

   The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

   Z-0366-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF AN 'INCREASED INCIDENCE OF LOW VALUES' WHEN USING INTACT PTH LOT 387 ON AN IMMULITE 2000 XPI INSTRUMENT. THE CUSTOMER PROVIDED THE RESULTS OF EIGHT PATIENTS COMPARED TO AN ALTERNATE, NON-SIEMENS, METHOD. THE IMMULITE 2000 XPI RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). QUALITY CONTROL (QC) WAS WITHIN ACCEPTABLE RANGES AT THE TIME OF TESTING. CLINICAL CONTEXT IS UNKNOWN AND THE REFERENCE RANGE FOR THE ALTERNATE METHOD IS UNKNOWN AS WELL. 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 24055532 ↗
• MalfunctionNov 15, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY LOW RESULT (BELOW REFERENCE RANGE OF THE ASSAY ) WAS OBTAINED ON A PATIENT SAMPLE FOR INTACT PARATHYROID (IPTH) ASSAY ON AN IMMULITE 2000 (INSTRUMENT 1) INSTRUMENT WHEN USING IPTH KIT LOT 332. THE INITIAL RESULT OBTAINED ON INSTRUMENT 1 WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS THEN REPEATED ON ANOTHER IMMULITE 2000 INSTRUMENT (INSTRUMENT 2) IN THE SAME LABORATORY TWICE USING IPTH KIT LOT 333 AND THE RESULT WAS STILL LOW (BELOW REFERENCE RANGE OF THE ASSAY). THE RESULT OBTAINED ON INSTRUMENT 2 WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN TESTED ON AN ALTERNATE NON-SIEMENS PLATFORM AND THE RESULT WAS WITHIN THE REFERENCE RANGE OF THAT ASSAY. THE CUSTOMER IS UNCLEAR WHAT THE TRUE EXPECTED RESULT IS BUT HAS INDICATED THAT THE PHYSICIAN(S) EXPECTED A RESULT HIGHER THAN THE RESULT ON INSTRUMENT 1. THERE WERE NO PREVIOUS IPTH RESULTS ON THIS PATIENT SAMPLE. THE CUSTOMER HAS INDICATED THAT QUALITY CONTROL SAMPLES RECOVERED WITHIN SPECIFICATIONS ON THE DAY THE DISCORDANT RESULT(S) WERE OBTAINED ON BOTH THE IMMULITE 2000 INSTRUMENTS, AND THAT THE SAMPLE WAS FROZEN IN BETWEEN TESTING ON THE INSTRUMENT(S). THERE ARE NO REPORTS OF PATIENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074744 ↗
• MalfunctionNov 15, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY LOW RESULT (BELOW REFERENCE RANGE OF THE ASSAY ) WAS OBTAINED ON A PATIENT SAMPLE FOR INTACT PARATHYROID (IPTH) ASSAY ON AN IMMULITE 2000 (INSTRUMENT 1) INSTRUMENT WHEN USING IPTH KIT LOT 332. THE INITIAL RESULT OBTAINED ON INSTRUMENT 1 WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAMPLE WAS THEN REPEATED ON ANOTHER IMMULITE 2000 INSTRUMENT (INSTRUMENT 2) IN THE SAME LABORATORY TWICE USING IPTH KIT LOT 333 AND THE RESULT WAS STILL LOW (BELOW REFERENCE RANGE OF THE ASSAY). THE RESULT OBTAINED ON INSTRUMENT 2 WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN TESTED ON AN ALTERNATE NON-SIEMENS PLATFORM AND THE RESULT WAS WITHIN THE REFERENCE RANGE OF THAT ASSAY. THE CUSTOMER IS UNCLEAR WHAT THE TRUE EXPECTED RESULT IS BUT HAS INDICATED THAT THE PHYSICIAN(S) EXPECTED A RESULT HIGHER THAN THE RESULT ON INSTRUMENT 1. THERE WERE NO PREVIOUS IPTH RESULTS ON THIS PATIENT SAMPLE. THE CUSTOMER HAS INDICATED THAT QUALITY CONTROL SAMPLES RECOVERED WITHIN SPECIFICATIONS ON THE DAY THE DISCORDANT RESULT(S) WERE OBTAINED ON BOTH THE IMMULITE 2000 INSTRUMENTS, AND THAT THE SAMPLE WAS FROZEN IN BETWEEN TESTING ON THE INSTRUMENT(S). THERE ARE NO REPORTS OF PATIENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074739 ↗
• MalfunctionNov 5, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY LOW RESULT (BELOW REFERENCE RANGE OF THE ASSAY) WAS OBTAINED ON A PATIENT SAMPLE FOR INTACT PARATHYROID (IPTH) ASSAY ON AN IMMULITE 2000 (INSTRUMENT 1) INSTRUMENT WHEN USING IPTH KIT LOT 331. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER IMMULITE 2000 INSTRUMENT (INSTRUMENT 2) IN THE SAME LABORATORY USING THE SAME IPTH KIT LOT 331 AND THE RESULT WAS STILL LOW. THE SAMPLE WAS THEN REPEATED ON INSTRUMENT 1 AND 2 WITH IPTH KIT LOT 332 AND THE RESULTS WERE STILL LOW. THE SAMPLE WAS THEN REPEATED MULTIPLE TIMES THE NEXT DAY ON INSTRUMENT 2 WITH KIT LOT 332 AND THE RESULT WAS LOW AGAIN. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER SOME REPLICATES OF QUALITY CONTROL SAMPLES LEVELS 1 AND 2 WERE OUTSIDE OF ACCEPTABLE SPECIFICATIONS ON THE DAY THE DISCORDANT SAMPLES WERE OBTAINED. THE CUSTOMER HAS INDICATED THAT THEY RUN MULTIPLE ASSAY ON THE TWO IMMULITE INSTRUMENTS BUT HAVE NOT REPORTED ANY DISCORDANT PATIENT RESULTS. THERE WERE NO ERROR MESSAGES ON THE SYSTEM WHEN THE DISCORDANT RESULTS WERE OBTAINED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE HANDLING AS THE SAMPLE WAS RUN MULTIPLE TIMES ON THE TWO SYSTEMS WITH DIFFERENT IPTH KIT LOTS. THE INITIAL LOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038878 ↗
• MalfunctionNov 5, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY LOW RESULT (BELOW REFERENCE RANGE OF THE ASSAY ) WAS OBTAINED ON A PATIENT SAMPLE FOR INTACT PARATHYROID (IPTH) ASSAY ON AN IMMULITE 2000 (INSTRUMENT 1) INSTRUMENT WHEN USING IPTH KIT LOT 331. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER IMMULITE 2000 INSTRUMENT (INSTRUMENT 2) IN THE SAME LABORATORY USING THE SAME IPTH KIT LOT 331 AND THE RESULT WAS STILL LOW. THE SAMPLE WAS THEN REPEATED ON INSTRUMENT 1 AND 2 WITH IPTH KIT LOT 332 AND THE RESULTS WERE STILL LOW. THE SAMPLE WAS THEN REPEATED MULTIPLE TIMES THE NEXT DAY ON INSTRUMENT 2 WITH KIT LOT 332 AND THE RESULT WAS LOW AGAIN. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER SOME REPLICATES OF QUALITY CONTROL SAMPLES LEVELS 1 AND 2 WERE OUTSIDE OF ACCEPTABLE SPECIFICATIONS ON THE DAY THE DISCORDANT SAMPLES WERE OBTAINED. THE CUSTOMER HAS INDICATED THAT THEY RUN MULTIPLE ASSAY ON THE TWO IMMULITE INSTRUMENTS BUT HAVE NOT REPORTED ANY DISCORDANT PATIENT RESULTS. THERE WERE NO ERROR MESSAGES ON THE SYSTEM WHEN THE DISCORDANT RESULTS WERE OBTAINED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE HANDLING AS THE SAMPLE WAS RUN MULTIPLE TIMES ON THE TWO SYSTEMS WITH DIFFERENT IPTH KIT LOTS. THE INITIAL LOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038855 ↗
• MalfunctionNov 5, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY LOW RESULT (BELOW REFERENCE RANGE OF THE ASSAY ) WAS OBTAINED ON A PATIENT SAMPLE FOR INTACT PARATHYROID (IPTH) ASSAY ON AN IMMULITE 2000 (INSTRUMENT 1) INSTRUMENT WHEN USING IPTH KIT LOT 331. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER IMMULITE 2000 INSTRUMENT (INSTRUMENT 2) IN THE SAME LABORATORY USING THE SAME IPTH KIT LOT 331 AND THE RESULT WAS STILL LOW. THE SAMPLE WAS THEN REPEATED ON INSTRUMENT 1 AND 2 WITH IPTH KIT LOT 332 AND THE RESULTS WERE STILL LOW. THE SAMPLE WAS THEN REPEATED MULTIPLE TIMES THE NEXT DAY ON INSTRUMENT 2 WITH KIT LOT 332 AND THE RESULT WAS LOW AGAIN. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER SOME REPLICATES OF QUALITY CONTROL SAMPLES LEVELS 1 AND 2 WERE OUTSIDE OF ACCEPTABLE SPECIFICATIONS ON THE DAY THE DISCORDANT SAMPLES WERE OBTAINED. THE CUSTOMER HAS INDICATED THAT THEY RUN MULTIPLE ASSAY ON THE TWO IMMULITE INSTRUMENTS BUT HAVE NOT REPORTED ANY DISCORDANT PATIENT RESULTS. THERE WERE NO ERROR MESSAGES ON THE SYSTEM WHEN THE DISCORDANT RESULTS WERE OBTAINED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE HANDLING AS THE SAMPLE WAS RUN MULTIPLE TIMES ON THE TWO SYSTEMS WITH DIFFERENT IPTH KIT LOTS. THE INITIAL LOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038849 ↗
• MalfunctionNov 5, 2018Low Test Results; Low Test Results

  A DISCORDANT FALSELY LOW RESULT (BELOW REFERENCE RANGE OF THE ASSAY ) WAS OBTAINED ON A PATIENT SAMPLE FOR INTACT PARATHYROID (IPTH) ASSAY ON AN IMMULITE 2000 (INSTRUMENT 1) INSTRUMENT WHEN USING IPTH KIT LOT 331. THE SAMPLE WAS REPEATED THE NEXT DAY ON ANOTHER IMMULITE 2000 INSTRUMENT (INSTRUMENT 2) IN THE SAME LABORATORY USING THE SAME IPTH KIT LOT 331 AND THE RESULT WAS STILL LOW. THE SAMPLE WAS THEN REPEATED ON INSTRUMENT 1 AND 2 WITH IPTH KIT LOT 332 AND THE RESULTS WERE STILL LOW. THE SAMPLE WAS THEN REPEATED MULTIPLE TIMES THE NEXT DAY ON INSTRUMENT 2 WITH KIT LOT 332 AND THE RESULT WAS LOW AGAIN. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, SOME REPLICATES OF QUALITY CONTROL SAMPLES LEVELS 1 AND 2 WERE OUTSIDE OF ACCEPTABLE SPECIFICATIONS ON THE DAY THE DISCORDANT SAMPLES WERE OBTAINED. THE CUSTOMER HAS INDICATED THAT THEY RUN MULTIPLE ASSAY ON THE TWO IMMULITE INSTRUMENTS BUT HAVE NOT REPORTED ANY DISCORDANT PATIENT RESULTS. THERE WERE NO ERROR MESSAGES ON THE SYSTEM WHEN THE DISCORDANT RESULTS WERE OBTAINED. THE CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE HANDLING AS THE SAMPLE WAS RUN MULTIPLE TIMES ON THE TWO SYSTEMS WITH DIFFERENT IPTH KIT LOTS. THE INITIAL LO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038840 ↗
• MalfunctionOct 8, 2018Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED RESULTS WERE OBTAINED ON PATIENT SAMPLES FOR THE INTACT PARATHYROID (IPTH) ASSAY ON KIT LOT 333 COMPARED TO KIT LOT 329 ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULTS OBTAINED ON KIT LOT 333 WERE LOWER THAN THE RESULTS OBTAINED ON KIT LOT 329 FOR THE SAME SAMPLES. THE FALSELY DEPRESSED RESULTS ON KIT LOT 333 WERE REPORTED TO THE PHYSICIAN(S).THE CUSTOMER RAN SAMPLES ON SEPTEMBER 4 AND 6, BUT DID NOT INDICATE TO SIEMENS WHICH SAMPLES WERE RUN ON WHICH DAY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED IPTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7944002 ↗
• MalfunctionOct 8, 2018Low Test Results; Low Test Results

  DISCORDANT, FALSELY DEPRESSED RESULTS WERE OBTAINED ON PATIENT SAMPLES FOR THE INTACT PARATHYROID (IPTH) ASSAY ON KIT LOT 333 COMPARED TO KIT LOT 329 ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULTS OBTAINED ON KIT LOT 333 WERE LOWER THAN THE RESULTS OBTAINED ON KIT LOT 329 FOR THE SAME SAMPLES. THE FALSELY DEPRESSED RESULTS ON KIT LOT 333 WERE REPORTED TO THE PHYSICIAN(S).THE CUSTOMER RAN SAMPLES ON (B)(6), BUT DID NOT INDICATE TO SIEMENS WHICH SAMPLES WERE RUN ON WHICH DAY. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED IPTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7943994 ↗
• MalfunctionSep 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY DEPRESSED RESULTS WERE OBTAINED FOR PATIENT SAMPLES WITH THE IMMULITE 2000 INTACT PTH (PARATHYRIN) ASSAY. THE INITIAL DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED WITH A DIFFERENT REAGENT LOT OF THE SAME ASSAY AND RESULTED HIGHER. THE REPEAT RESULTS WERE IN ALIGNMENT WITH THE CLINICAL PROFILE OF THE PATIENTS. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ANY IMPACT TO PATIENT TREATMENT OR INTERVENTION DUE TO THE DISCORDANT, FALSELY DEPRESSED INTACT PTH RESULTS. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENTS DUE TO THE DISCORDANT, FALSELY DEPRESSED INTACT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880511 ↗
• MalfunctionSep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT RESULTS WERE OBTAINED FOR PATIENT SAMPLES WITH THE IMMULITE 2000 XPI INTACT PTH (PARATHYRIN) ASSAY. THE SAMPLES WERE REPEATED ON AN ALTERNATE PLATFORM OR ON THE SAME ASSAY AND RESULTED HIGHER. IT IS NOT KNOWN IF ANY OF THE RESULTS WERE REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ANY IMPACT TO PATIENT TREATMENT OR INTERVENTION DUE TO THE DISCORDANT INTACT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855370 ↗
• MalfunctionApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY HIGH RESULT WAS OBTAINED FOR INTACT PARATHYROID (IPTH) ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHEN USING REAGENT LOT 326 ON (B)(6) 2018. THE CUSTOMER WAS EXPECTING THE RESULT TO BE IN THE NORMAL RANGE. THE SAMPLE WAS THEN DILUTED AND RUN ON THE SAME IMMULITE 2000 INSTRUMENT ON (B)(6) 2018 AND THE VALUES OBTAINED WERE LOWER. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE RESULTS ON THE DILUTED SAMPLE WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RUN NEAT AND DILUTED ON AN ALTERNATE PLATFORM AND THE RESULTS ON BOTH SAMPLES WERE LOWER THAN WHAT WAS OBTAINED ON THE DILUTED SAMPLE ON THE IMMULITE PLATFORM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY HIGH IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444693 ↗
• MalfunctionApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY HIGH RESULT WAS OBTAINED FOR INTACT PARATHYROID (IPTH) ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHEN USING REAGENT LOT 326 ON (B)(6) 2018. THE SAMPLE WAS TREATED WITH HETEROPHILE ANTIBODY BLOCKING TUBE (HBT) ON (B)(6) 2018 AND RUN NEAT, BUT RECOVERED FALSELY HIGH AGAIN. THE CUSTOMER WAS EXPECTING THE RESULT TO BE IN THE NORMAL RANGE. THE SAMPLE WAS THEN DILUTED AND RUN ON THE SAME IMMULITE 2000 INSTRUMENT AND THE VALUES OBTAINED WERE ACCEPTABLE TO THE CUSTOMER BASED ON PRIOR IPTH RESULTS OBTAINED FOR THIS SAMPLE. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE RESULTS ON THE DILUTED SAMPLE WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY HIGH IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444692 ↗
• MalfunctionApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY HIGH RESULT WAS OBTAINED FOR INTACT PARATHYROID (IPTH) ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHEN USING REAGENT LOT 326 ON (B)(6) 2018. THE SAMPLE WAS TREATED WITH HETEROPHILE ANTIBODY BLOCKING TUBE (HBT) ON (B)(6) 2018 AND RUN NEAT, BUT RECOVERED FALSELY HIGH AGAIN. THE CUSTOMER WAS EXPECTING THE RESULT TO BE IN THE NORMAL RANGE. THE SAMPLE WAS THEN DILUTED AND RUN ON THE SAME IMMULITE 2000 INSTRUMENT AND THE VALUES OBTAINED WERE ACCEPTABLE TO THE CUSTOMER BASED ON PRIOR IPTH RESULTS OBTAINED FOR THIS SAMPLE. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE RESULTS ON THE DILUTED SAMPLE WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSE ELEVATED IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444691 ↗
• MalfunctionApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY HIGH RESULT WAS OBTAINED FOR INTACT PARATHYROID (IPTH) ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHEN USING REAGENT LOT 326 ON (B)(6) 2018. THE CUSTOMER WAS EXPECTING THE RESULT TO BE IN THE NORMAL RANGE. THE SAMPLE WAS THEN DILUTED AND RUN ON THE SAME IMMULITE 2000 INSTRUMENT ON (B)(6) 2018 AND THE VALUES OBTAINED WERE LOWER. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE RESULTS ON THE DILUTED SAMPLE WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RUN NEAT AND DILUTED ON AN ALTERNATE PLATFORM AND THE RESULTS ON BOTH SAMPLES WERE LOWER THAN WHAT WAS OBTAINED ON THE DILUTED SAMPLE ON THE IMMULITE PLATFORM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY HIGH IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444689 ↗
• MalfunctionOct 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE (INTACT PTH) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 325. ON (B)(6) 2017, THE CUSTOMER HAD OBTAINED A DIFFERENT PATIENT SAMPLE AND RAN IT ON THE SAME INSTRUMENT, USING SAME KIT LOT, ALSO RESULTING LOW. THE SAMPLE FROM (B)(6) 2017 (ALIQUOT AND PRIMARY TUBE) WAS SENT TO AN ALTERNATE LABORATORY WHERE IT WAS TESTED ON AN ALTERNATE PLATFORM USING A NEW INTACT PTH ASSAY, RESULTING HIGHER. THE PRIMARY TUBE FOR THE SAMPLE FROM (B)(6) 2017 WAS THEN TESTED USING OLD INTACT PTH ASSAY ON AN ALTERNATE PLATFORM, ALSO RESULTING HIGHER. THE DISCORDANT RESULTS OBTAINED FOR THE SAMPLE FROM (B)(6) 2017 WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW INTACT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6913353 ↗
• MalfunctionOct 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW INTACT PARATHYROID HORMONE (INTACT PTH) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 325. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS RUN ON THE SAME INSTRUMENT USING SAME KIT LOT, ALSO RESULTING LOW. THE REDRAWN SAMPLE (ALIQUOT AND PRIMARY TUBE) WAS SENT TO AN ALTERNATE LABORATORY WHERE IT WAS TESTED ON AN ALTERNATE PLATFORM USING A NEW INTACT PTH ASSAY, RESULTING HIGHER. THE PRIMARY TUBE FOR THE REDRAWN SAMPLE WAS THEN TESTED USING OLD INTACT PTH ASSAY ON AN ALTERNATE PLATFORM, ALSO RESULTING HIGHER. THE DISCORDANT RESULTS OBTAINED FROM THE ORIGINAL SAMPLE DRAW WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW INTACT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6913352 ↗
• MalfunctionJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOW INTACT PTH RESULTS WERE OBTAINED WITH KIT LOT 323 ON AN IMMULITE 2000 XPI INSTRUMENT WHEN COMPARED TO AN ALTERNATE PLATFORM. IT IS NOT KNOWN IF THE INITIAL RESULTS FOR EACH OF THE SAMPLES WERE REPORTED TO PHYSICIAN(S) OR IF REPEAT TESTING WAS PERFORMED ON EACH SAMPLE TO CONFIRM THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE LOW INTACT PTH RESULTS. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO PATIENTS DUE TO THE LOW INTACT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6678599 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013566. One submission often covers many models, so check the product and lot details in each record.

• Z-0979-2017 · Nov 22, 2016 · Terminated
  SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L
• Z-0724-04 · Feb 23, 2004 · Terminated
  IMMULITE 2000 Intact PTH kit