IMMULITE® 2000 Systems PRG Progesterone 10381181Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414961972), received between Oct 27, 2017 and Oct 27, 2017 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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