Recall Z-1398-2024— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-02-29. It names one FDA 510(k) clearance: K132674. 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 fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.. Reason: Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results.
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-29
- Firm location
- Sparks, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
Reason for recall
Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
Data sourced from openFDA. This site is unofficial and independent of the FDA.