IMMULITE® 2000 Systems PRG Progesterone 10381170Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414961989), received between Aug 27, 2021 and Aug 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K944211); 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. Jul 10, 2019Class IITerminated

   There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.

   Z-2290-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021High Test Results; High Test Results

  A CUSTOMER OBTAINED A FALSELY ELEVATED IMMULITE 2000 PROGESTERONE RESULT FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED WITH AN ALTERNATE METHOD IN A DIFFERENT LABORATORY AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATES THAT IVF TREATMENT WAS WITHHELD DUE TO FALSE ELEVATED PROGESTERONE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 PROGESTERONE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378791 ↗
• MalfunctionAug 27, 2021High Test Results; High Test Results

  A CUSTOMER OBTAINED FALSELY ELEVATED IMMULITE 2000 PROGESTERONE RESULTS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED WITH A DIFFERENT REAGENT LOT AND RESULT WAS ELEVATED. THE SAMPLE WAS RETESTED WITH AN ALTERNATE METHOD IN A DIFFERENT LABORATORY AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATES THAT IVF TREATMENT WAS WITHHELD DUE TO FALSE ELEVATED PROGESTERONE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 PROGESTERONE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378789 ↗
• MalfunctionAug 27, 2021High Test Results; High Test Results

  A CUSTOMER OBTAINED FALSELY ELEVATED IMMULITE 2000 PROGESTERONE RESULTS FOR AN IN-VITRO FERTILIZATION (IVF) PATIENT. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED WITH A DIFFERENT REAGENT LOT AND RESULT WAS ELEVATED. THE SAMPLE WAS RETESTED WITH AN ALTERNATE METHOD IN A DIFFERENT LABORATORY AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER STATES THAT IVF TREATMENT WAS WITHHELD DUE TO FALSE ELEVATED PROGESTERONE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED IMMULITE 2000 PROGESTERONE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K944211. One submission often covers many models, so check the product and lot details in each record.

• Z-0524-2009 · Jul 21, 2008 · Terminated
  IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in seru