IMMULITE®2000 Systems 3gAllergy™ Rat 10385672Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414996554), received between May 22, 2018 and May 22, 2018 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K021206); 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.

• MalfunctionMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSE NEGATIVE 3GALLERGY SPECIFIC IGE RESULT FOR RAT ALLERGEN (E87) (510 (K) # K021206) WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING AN UNKNOWN KIT LOT. THE SAMPLE WAS ALSO TESTED NEGATIVE FOR RAT EPITHELIUM ALLERGEN (E73) (510 (K) # K013134). THE SAMPLE WAS REPEATED ON AN ALTERNATE PLATFORM FOR ALLERGENS E87 AND E73, RESULTING POSITIVE. IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3GALLERGY SPECIFIC IGE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533657 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021206. One submission often covers many models, so check the product and lot details in each record.

• Z-0491-2026 · Oct 6, 2025 · Open, Classified
  IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;