IMMULITE®2000 Systems 3gAllergy™ Timothy Grass 10385924Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414960579), received between Mar 28, 2023 and Mar 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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

• MalfunctionMar 28, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED RESULT WITH SPECIFIC IGE ON IMMULITE 2000 FOR TIMOTHY GRASS (LOT 624) COMPARED TO A HIGHER RESULT OBSERVED WITH TIMOTHY GRASS (LOT 625). THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED ALLERGEN SPECIFIC IGE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628545 ↗

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