BD BACTEC™ 9120, Remanufactured 445702Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904457020), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K922475); 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. Sep 23, 2025Class IIOpen, Classified

   Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

   Z-0237-2026 · Root cause: Software design · 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.

• MalfunctionApr 20, 2021False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ 9120, REMANUFACTURED FALSE POSITIVE RESULTS WERE OBTAINED IN RACK C AND D. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CLIENT HAS BEEN CLAIMING THAT RACK C AND D HAVE BEEN PRESENTING SOME CASES OF FALSE POSITIVES, TO SOLVE THIS PROBLEM WE CARRY OUT CALIBRATIONS OF ALL RACKS AS WELL AS RESTORING FACTORY DEFAULTS ACCORDING TO THE MANUFACTURER'S MANUAL PROCEDURE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11696069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K922475. One submission often covers many models, so check the product and lot details in each record.

• Z-0595-2025 · Oct 31, 2024 · Open, Classified
  BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570