IMMULITE 2000 Systems PTS PSARecalls & reported problems across all models

We found 2 models of IMMULITE 2000 Systems PTS PSA by Siemens Healthcare Diagnostics Products Ltd in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.

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

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 PTS PSA 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. Sep 30, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported IMMULITE 2000 Systems PTS PSA problems

IMMULITE 2000 Systems PTS PSA models

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

• IMMULITE® 2000 Systems PTS PSA 10706281

  Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
  1 recall1 report
• IMMULITE® 2000 Systems PTS PSA 10706282

  Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
  1 recall0 reports

Recent IMMULITE 2000 Systems PTS PSA adverse event reports

The 1 most recent reports across all models, 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 ↗

Other Siemens Healthcare Diagnostics Products Ltd products

• IMMULITE 2000 Systems HCG2 models · 189 reports · 1 recall
• IMMULITE 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab)2 models · 17 reports · 2 recalls
• IMMULITE 2000 Systems E2 Estradiol2 models · 40 reports · 1 recall
• IMMULITE 2000 Systems IPT Intact PTH2 models · 18 reports · 1 recall
• IMMULITE 2000 Systems PRG Progesterone2 models · 7 reports · 1 recall