IMMULITE® 2000 Systems TIE Total IgE 10380873Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414966083), received between Aug 25, 2017 and Aug 25, 2017 — classified as 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K931703); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPRECISE CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING REAGENT KIT LOT 283. IT IS UNKNOWN WHICH RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE IMPRECISE CTNI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6821318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K931703. One submission often covers many models, so check the product and lot details in each record.

• Z-1517-2014 · Dec 20, 2013 · Terminated
  IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE
• Z-1518-2014 · Dec 20, 2013 · Terminated
  IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagn