IMMULITE® 2000 Systems TSH Third Generation TSH 10381665Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414962160), received between Aug 13, 2019 and Aug 14, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

13 other recalls cover devices cleared under the same FDA submission (K970227); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI. THE REPEAT RESULT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER COULD NOT CONFIRM THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TSH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8895261 ↗
• MalfunctionAug 13, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED THYROID STIMULATING HORMONE (TSH) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI. THE REPEAT RESULT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER COULD NOT CONFIRM THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TSH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8890836 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970227. One submission often covers many models, so check the product and lot details in each record.

• Z-2469-2020 · May 15, 2020 · Terminated
  Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
• Z-2470-2020 · May 15, 2020 · Terminated
  Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
• Z-1663-2015 · Mar 5, 2015 · Terminated
  Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instru
• Z-1662-2015 · Mar 5, 2015 · Terminated
  Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use se
• Z-1660-2015 · Mar 5, 2015 · Terminated
  Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instrume
• Z-1661-2015 · Mar 5, 2015 · Terminated
  Direct Water feed Kit, Catalog#10373222
• Z-1658-2015 · Mar 5, 2015 · Terminated
  Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instr
• Z-1832-2014 · Apr 25, 2014 · Terminated
  VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes sam
• Z-1316-2014 · Feb 3, 2014 · Terminated
  IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use ser
• Z-1033-2010 · Oct 21, 2009 · Terminated
  IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
• Z-1891-2010 · May 15, 2009 · Terminated
  IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
• Z-1399-2009 · Jan 5, 2009 · Terminated
  Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnosti
• Z-0994-05 · Apr 22, 2005 · Terminated
  IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836