IMMULITE® 1000 Immunoassay System 10380058Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630414947440), received between Dec 27, 2017 and Dec 18, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K022603); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FOUR DISCORDANT, FALSELY ELEVATED PROGESTERONE PATIENT RESULTS WERE OBTAINED ON AN IMMULITE 1000 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR 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 FALSELY ELEVATED PROGESTERONE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11040747 ↗
• MalfunctionFeb 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY HIGH INTACT PTH PATIENT RESULT WAS OBTAINED ON AN IMMULITE 1000 INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AGAIN ON AN ALTERNATE IMMULITE 1000 INSTRUMENT. THE REPEATED RESULT FROM THE ALTERNATE INSTRUMENT 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, FALSELY HIGH INTACT PTH PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742066 ↗
• MalfunctionJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULT WAS OBTAINED ON AN IMMULITE 1000 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED IN AN ALTERNATE LABORATORY, RESULTING LOWER. A CORRECTED REPORT WITH THE LOWER PROGESTERONE RESULT WAS ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSELY ELEVATED PROGESTERONE RESULT. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENTS DUE TO THE FALSELY ELEVATED PROGESTERONE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8241050 ↗
• MalfunctionNov 6, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY HIGH ENHANCED ESTRADIOL (EE2) TEST RESULT WAS OBTAINED FROM AN IMMULITE 1000 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT TWO DAYS LATER GIVING A LOWER RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND IS CONSIDERED CORRECT.THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY HIGH ENHANCED ESTRADIOL (EE2) TEST RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8041462 ↗
• MalfunctionAug 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED ON AN IMMULITE 1000 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. CORRECTED REPORTS WITH THE LOWER PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSELY ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENTS DUE TO THE FALSELY ELEVATED PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739547 ↗
• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY LOW RESULT WAS OBTAINED DURING SURGERY FOR TURBO INTACT PARATHYROID (IPTH) ON ONE PATIENT SAMPLE ON AN IMMULITE 1000 INSTRUMENT. THE PHYSICIAN(S) QUESTIONED THE RESULT EXPECTING IT TO BE HIGHER. THE SAMPLE WAS REPEATED TWICE ON THE SAME INSTRUMENT AND RESULTED HIGHER. THE HIGHER RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW TURBO IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542089 ↗
• MalfunctionDec 27, 2017Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY LOW THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 1000 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND RUN ON THE SAME INSTRUMENT, RESULTING HIGHER. ONE OF THE SAMPLE DRAW WAS SENT TO AN ALTERNATE LABORATORY WHERE IT WAS TESTED ON AN ALTERNATE PLATFORM, RESULTING HIGHER THAN THE INITIAL RESULT AND LOWER THAN THE INITIAL RESULT OF NEW SAMPLE DRAW. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE, WHICH RESULTED HIGHER. THE RERUN OF THE ORIGINAL SAMPLE DRAW WAS REPORTED AS A CORRECTED RESULT TO THE PHYSICIAN(S). ONE OF THE SAMPLE DRAW WAS AGAIN SENT TO THE ALTERNATE LABORATORY WHERE IT WAS TESTED ON THE ALTERNATE PLATFORM, RESULTING HIGHER THIS TIME. BOTH SAMPLE DRAWS WERE THEN SENT TO A REFERENCE LABORATORY WHERE THEY WERE TESTED ON A DIFFERENT ALTERNATE PLATFORM, ALSO RESULTING HIGHER. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW TSH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7148068 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022603. One submission often covers many models, so check the product and lot details in each record.

• Z-1700-2012 · Apr 30, 2012 · Terminated
  IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange Product Usage: For in vitro diagnostic use with IMMULITE and IMMUL
• Z-1701-2012 · Apr 30, 2012 · Terminated
  IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange --- Product Usage: For in vitro diagnostic use with IMMULITE