IMMULITE®2000 Systems 3gAllergy™ White Ash 10386060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414973548), received between Aug 4, 2017 and Aug 4, 2017 — classified as 4 malfunctions.

2 other recalls cover devices cleared under the same FDA submission (K013134); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED FOR T15 ALLERGEN (WHITE ASH ALLERGEN) WITH THE IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT ON (B)(6) 2017. THE SAMPLE WAS RE-TESTED WITH THE IMMULITE 2000 A482 ALLERGEN (NOLE E-1 ALLERGEN) ON THE SAME INSTRUMENT AND RESULTED POSITIVE. THE INITIAL RESULT WITH T15 ALLERGEN AND THE REPEAT RESULT WITH A482 ALLERGEN WERE PROVIDED TO PHYSICIAN(S). THE SAME SAMPLE HAD BEEN TESTED ON (B)(6)2017 ON THE T15 ALLERGEN, RESULTING FALSELY NEGATIVE AND ON THE A482 ALLERGEN, RESULTING POSITIVE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768821 ↗
• MalfunctionAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED FOR T15 ALLERGEN (WHITE ASH ALLERGEN) WITH THE IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULT. REPEAT TESTING ON THE T15 ALLERGEN ALSO RESULTED FALSELY NEGATIVE. THE SAMPLE WAS RE-TESTED WITH THE IMMULITE 2000 A482 ALLERGEN (NOLE E-1 ALLERGEN) ON THE SAME INSTRUMENT AND RESULTED POSITIVE. THE REPEAT RESULT WITH THE A482 ALLERGEN WAS ALSO PROVIDED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768814 ↗
• MalfunctionAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED FOR T15 ALLERGEN (WHITE ASH ALLERGEN) WITH THE IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RE-TESTED WITH THE IMMULITE 2000 A482 ALLERGEN (NOLE E-1 ALLERGEN) ON THE SAME INSTRUMENT AND RESULTED POSITIVE. THE SAMPLE WAS TESTED ON AN ALTERNATE PLATFORM WITH T25 ALLERGEN (ASH TREE ALLERGEN) AND RESULTED POSITIVE. THE REPEAT RESULTS WERE ALSO PROVIDED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768798 ↗
• MalfunctionAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED FOR T15 ALLERGEN (WHITE ASH ALLERGEN) WITH THE IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RE-TESTED WITH THE IMMULITE 2000 A482 ALLERGEN (NOLE E-1 ALLERGEN) ON THE SAME INSTRUMENT AND RESULTED POSITIVE. THE REPEAT RESULT WAS ALSO PROVIDED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSE NEGATIVE T15 ALLERGEN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768788 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013134. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2018 · Jan 2, 2018 · Terminated
  IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit
• Z-1843-2015 · May 6, 2015 · Terminated
  IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2