ImmunoCAP Allergen f202, Cashew nut 14-4835-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333066004471), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

3 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.

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.

• InjuryNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) REPORTED A PATIENT (CHILD) OF UNKNOWN AGE HAD AN ANAPHYLACTIC REACTION AFTER PREVIOUSLY TESTING NEGATIVE FOR IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO. A RETEST, AFTER ANAPHYLAXIS, FOR IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO WAS PERFORMED WITH POSITIVE RESULTS. THE PATIENT WAS TESTED USING IMMUNOCAP ALLERGEN F202, CASHEW NUT AND IMMUNOCAP ALLERGEN F203, PISTACHIO IN (B)(6) 2024 WITH NEGATIVE RESULTS. THE PATIENT THEN HAD AN ANAPHYLACTIC REACTION AND WAS RETESTED ON (B)(6) 2024, WHICH RESULTED IN POSITIVE RESULTS (IMMUNOCAP ALLERGEN F202, CASHEW NUT 0.84 KU/L AND IMMUNOCAP ALLERGEN F203, PISTACHIO 5.16 KU/L).

  Patient problems: Anaphylactoid / Anaphylaxis

  MAUDE report 20685965 ↗

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-2397-2019 · Jul 9, 2019 · Terminated
  Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is d
• 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
• 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