Phadia 1000 12-3800-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333066001005), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K051218); 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. Jul 9, 2019Class IITerminated

   code 7-102 Liquid Sensor Error

   Z-2397-2019 · 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 15, 2025Incorrect Measurement; Incorrect Measurement

  DISCREPANCIES WERE FOUND WITH A PATIENT'S RESULTS FOR MULTIPLE IMMUNOCAP ALLERGEN(S) / ALLERGEN COMPONENT(S). THE PATIENT SAMPLE WAS TESTED ON PHADIA 1000 INSTRUMENT (SERIAL NUMBER: (B)(6)) WITH IMMUNOCAP ALLERGEN(S) / ALLERGEN COMPONENT(S) YIELDING NEGATIVE RESULTS. THE SAMPLE WAS TESTED AGAIN ON ALTERNATE PHADIA 1000 INSTRUMENT (SERIAL NO: (B)(6)) WITH THE SAME IMMUNOCAP ALLERGEN(S) / ALLERGEN COMPONENT(S) AND YIELDED THE POSITIVE RESULTS. THE REPEAT TEST RESULTS ALIGNED MORE WITH THE PATIENT'S HISTORY.

  Patient problems: Insufficient Information

  MAUDE report 23303653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051218. One submission often covers many models, so check the product and lot details in each record.

• Z-1313-2018 · Dec 18, 2017 · Terminated
  ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human s
• Z-1312-2018 · Dec 18, 2017 · Terminated
  ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human seru