BD FOX™ Extraction Tubes 441129Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382904411290), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K081825); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 6, 2022Contamination; Contamination

  IT WAS REPORTED THAT BD FOX¿ EXTRACTION TUBES CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CONSECUTIVE ROUNDS OF DECONTAMINATION, CUSTOMER FOUND CONTAMINATION ON PRODUCT DURING AN ENVIRONMENTAL RUN AFTER CONSECUTIVE ROUNDS OF DECONTAMINATION OF THE LAB, CUSTOMER SWABBED THE INSIDE OF STATED REAGENT BOX AFTER USING FRESH PPE AND BEFORE THE REAGENT BOXES WERE PUT INTO THE LAB. CUSTOMER IS NOT RULING OUT THAT THE BOXES OF REAGENTS WERE CONTAMINATED BEFORE DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081825. One submission often covers many models, so check the product and lot details in each record.

• Z-1215-2013 · Feb 8, 2013 · Terminated
  BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amp