IMMULITE® 2000 Systems PTS PSA 10706281Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414982212), received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (P930027); 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. Sep 30, 2024Class IIOpen, Classified

   The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

   Z-0464-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. A NEW BLOOD DRAW WAS TAKEN FROM THE SAME PATIENT ON A DIFFERENT DATE AND WAS RUN ON THE DAY IT WAS DRAWN ON THE SAME IMMULITE 2000 INSTRUMENT AS THE PREVIOUS SAMPLE. THE RESULTS OF THE REPEAT OF THE INITIAL SAMPLE AND THE NEW BLOOD DRAW MATCHED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT FALSELY LOW PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481067 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P930027. One submission often covers many models, so check the product and lot details in each record.

• Z-1120-2017 · Dec 21, 2016 · Terminated
  IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMM
• Z-1119-2017 · Dec 21, 2016 · Terminated
  IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMM
• Z-0885-2017 · Nov 18, 2016 · Terminated
  IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catal
• Z-0884-2017 · Nov 18, 2016 · Terminated
  IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and
• Z-2047-2013 · Jun 26, 2013 · Terminated
  PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers
• Z-2090-2008 · May 21, 2008 · Terminated
  COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy.