IMMULITE®2000 Systems 3gAllergy™ Oak Mix 10386105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414965970), received between Oct 21, 2025 and Oct 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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

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. Oct 6, 2025Class IIOpen, Classified

   The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

   Z-0491-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionOct 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER INDICATED THAT THE IMMULITE 2000 OAK MIX SPECIFIC ALLERGEN LOT 627 WAS SCANNED USING A ZEBRA BARCODE SCANNER AND WAS LOADED ONTO AN IMMULITE 2000 XPI INSTRUMENT. THE CUSTOMER CONFIRMED THAT IMMULITE 2000 OAK MIX SPECIFIC ALLERGEN LOT 627 IS NOT IN USE. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA AND DID NOT INDICATE THAT ERRONEOUS PATIENT RESULTS WERE OBTAINED. HOWEVER, IF THE ORDER OF TUBES WITHIN THE ALLERGEN HOLDER WEDGE IS INCORRECT THERE IS A POTENTIAL FOR PATIENT SAMPLE RESULTS TO BE INACCURATE FOR ANY ALLERGEN LOADED IN THE SAME ALLERGEN HOLDER WEDGE AS IMMULITE 2000 OAK MIX SPECIFIC ALLERGEN LOT 627. IT IS UNKNOWN IF OTHER ALLERGEN TUBES WERE LOADED IN THE SAME ALLERGEN HOLDER WEDGE WHICH WERE TESTED/REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352997 ↗