IMMULITE® 2000 Systems SPE Specific IgE Universal Kit 10708840Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414982939), received between Jun 21, 2024 and Jun 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K101572); 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.

Recalls naming this device

1. Nov 4, 2022Class IIOpen, Classified

   Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

   Z-0716-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUS DEPRESSED RESULTS WHEN COMPARED TO AN ALTERNATE METHOD FOR ONE PATIENT WHEN USING ALLERGEN SPECIFIC IGE KIT LOT 121. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED USING AN ALTERNATE METHOD AND THE HIGHER REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS. A SECOND SAMPLE FROM THE SAME PATIENT WAS DRAWN AT A LATER DATE AND TESTING WAS REPEATED. THE REPEAT RESULTS REMAINED ERRONEOUSLY DEPRESSED WHEN COMPARED TO AN ALTERNATE METHOD. THE HIGHER REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584511 ↗
• MalfunctionJun 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUS DEPRESSED RESULTS WHEN COMPARED TO AN ALTERNATE METHOD FOR ONE PATIENT WHEN USING ALLERGEN SPECIFIC IGE KIT LOT 121. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED USING AN ALTERNATE METHOD AND THE HIGHER REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS. A SECOND SAMPLE FROM THE SAME PATIENT WAS DRAWN AT A LATER DATE AND TESTING WAS REPEATED. THE REPEAT RESULTS REMAINED ERRONEOUSLY DEPRESSED WHEN COMPARED TO AN ALTERNATE METHOD. THE HIGHER REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584507 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101572. One submission often covers many models, so check the product and lot details in each record.

• Z-0492-2026 · Oct 6, 2025 · Open, Classified
  3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number
• Z-0718-2023 · Nov 4, 2022 · Open, Classified
  IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human
• Z-0717-2023 · Nov 4, 2022 · Open, Classified
  IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific