IMMULITE®2000 Systems 3gAllergy™ Food Panel 5 10385897Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630414960432), received between Feb 8, 2021 and Feb 8, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (7 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE (CLASS 0) RESULT USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WAS DISCORDANT RELATIVE TO A POSITIVE (CLASS 1) REPEAT-TESTING RESULT OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296512 ↗
• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE (CLASS 0) RESULT USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WAS DISCORDANT RELATIVE TO A POSITIVE (CLASS 1) REPEAT-TESTING RESULT OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296439 ↗
• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE (CLASS 0) RESULT USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WAS DISCORDANT RELATIVE TO A POSITIVE (CLASS 1) REPEAT-TESTING RESULT OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296419 ↗
• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE (CLASS 0) RESULT USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WAS DISCORDANT RELATIVE TO A POSITIVE (CLASS 1) REPEAT-TESTING RESULT OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296405 ↗
• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE (CLASS 0) RESULT USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WAS DISCORDANT RELATIVE TO A POSITIVE (CLASS 2) REPEAT-TESTING RESULT OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296401 ↗
• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED NEGATIVE (CLASS 0) RESULTS FOR TWO PATIENTS USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WERE DISCORDANT RELATIVE TO POSITIVE (CLASS 1) REPEAT-TESTING RESULTS OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296385 ↗
• MalfunctionFeb 8, 2021False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A NEGATIVE (CLASS 0) RESULT USING THE IMMULITE 2000 FOOD PANEL 5 ASSAY, REAGENT LOT 620, WHICH WAS DISCORDANT RELATIVE TO A POSITIVE (CLASS 1) REPEAT-TESTING RESULT OBTAINED USING REAGENT LOT 621 OF THE SAME PRODUCT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11296380 ↗