The Recall Desk
HighFDA (Devices)·Z-1398-2024·Announced 2024-04-10

BD Phoenix diagnostic panel recalled for drug cross-contamination

Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II diagnostic device with confirmed drug cross-contamination and potential for diagnostic errors impacting clinical treatment decisions. No hospitalizations, illnesses, or actual patient harm have been reported.

Plain-English summary

Becton Dickinson & Co. is recalling the BD Phoenix NMIC-306 Panel, a diagnostic microbiology panel used with BD Phoenix Automated Microbiology Systems to identify bacteria in clinical samples. The affected lot (number 3318700, expiration November 7, 2024) contains 11,800 units.

The panels were found to have confirmed drug cross-contamination prior to release. This contamination may lead to incorrect, inadequate, or absent antibiotic treatment recommendations if laboratories rely on the contaminated panels' test results for bacterial identification.

The affected products were distributed worldwide, including throughout the United States and to Argentina, Belgium, Colombia, India, Japan, Peru, Paraguay, Singapore, Taiwan, and Uruguay. Clinical laboratories and healthcare facilities using this product are potentially affected if they received the recalled lot.

The recalled product

Product
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
Manufacturer
Becton Dickinson & Co.
Hazard
  • contamination
  • diagnostic-error

Distribution

Distributed nationwide across the United States.