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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 11,800
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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