IMMULITE® 2000 Systems Herpes I and II IgG 10381333Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00630414999784), received between Aug 20, 2019 and May 15, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED WITH (B)(6) ON IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10062409 ↗
• MalfunctionAug 20, 2019Low Test Results; Low Test Results

  ONE (B)(6) RESULT WAS OBTAINED WITH (B)(6) LOT 303 ON IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI INSTRUMENT AND HVG REAGENT LOT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE HVG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913179 ↗
• MalfunctionAug 20, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, (B)(6) RESULT WAS OBTAINED WITH (B)(6) LOT 303 ON IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI INSTRUMENT AND (B)(6) REAGENT LOT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913171 ↗
• MalfunctionAug 20, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSE (B)(6) RESULT WAS OBTAINED WITH (B)(6) LOT 303 ON IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI INSTRUMENT AND HVG REAGENT LOT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913168 ↗
• MalfunctionAug 20, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSE NEGATIVE RESULT WAS OBTAINED WITH HERPES SIMPLEX I/II IGG (HVG) LOT 303 ON IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME IMMULITE 2000 XPI INSTRUMENT AND HVG REAGENT LOT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE NEGATIVE HVG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913167 ↗