IMMULITE 2000 Systems PRG ProgesteroneRecalls & reported problems across all models

We found 2 models of IMMULITE 2000 Systems PRG Progesterone by Siemens Healthcare Diagnostics Products Ltd in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2017 and Aug 27, 2021 — classified as 7 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

IMMULITE 2000 Systems PRG Progesterone recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 10, 2019Terminated

   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 · names 2 of these models · Recall details · FDA record ↗

Most reported IMMULITE 2000 Systems PRG Progesterone problems

IMMULITE 2000 Systems PRG Progesterone models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IMMULITE® 2000 Systems PRG Progesterone 10381181

  RADIOIMMUNOASSAY, PROGESTERONE
  1 recall4 reports
• IMMULITE® 2000 Systems PRG Progesterone 10381170

  RADIOIMMUNOASSAY, PROGESTERONE
  1 recall3 reports

Recent IMMULITE 2000 Systems PRG Progesterone adverse event reports

The 7 most recent reports across all models, 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 ↗
• MalfunctionOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULTS WERE OBTAINED WITH MULTIPLE SAMPLE DRAWS ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHILE USING KIT LOT 482. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLE HAS NOT BEEN REPEATED TO VERIFY THE RESULT. HOWEVER, THE CUSTOMER EXPECTS THE RESULT TO BE LOWER. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6984002 ↗
• MalfunctionOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULTS WERE OBTAINED WITH MULTIPLE SAMPLE DRAWS ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHILE USING KIT LOT 482. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLE HAS NOT BEEN REPEATED TO VERIFY THE RESULT. HOWEVER, THE CUSTOMER EXPECTS THE RESULT TO BE LOWER. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6983994 ↗
• MalfunctionOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULTS WERE OBTAINED WITH MULTIPLE SAMPLE DRAWS ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHILE USING KIT LOT 482. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLE HAS NOT BEEN REPEATED TO VERIFY THE RESULT. HOWEVER, THE CUSTOMER EXPECTS THE RESULT TO BE LOWER. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6983981 ↗
• MalfunctionOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULTS WERE OBTAINED WITH MULTIPLE SAMPLE DRAWS ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHILE USING KIT LOT 482. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLE HAS NOT BEEN REPEATED TO VERIFY THE RESULT. HOWEVER, THE CUSTOMER EXPECTS THE RESULT TO BE LOWER. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED PROGESTERONE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6983967 ↗

Other Siemens Healthcare Diagnostics Products Ltd products

• IMMULITE 2000 Systems HCG2 models · 189 reports · 1 recall
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• IMMULITE 2000 Systems E2 Estradiol2 models · 40 reports · 1 recall
• IMMULITE 2000 Systems IPT Intact PTH2 models · 18 reports · 1 recall
• IMMULITE 2000 Systems PTS PSA2 models · 1 reports · 1 recall