Recall Z-3246-2024— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-08-01. It names 3 FDA 510(k) clearances: K131331, K040099, K020321. Product: BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624. Reason: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,.
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-01
- Firm location
- Sparks, MD, United States
510(k) clearances named in this recall
3 on FDA's record- K131331 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
- K040099 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K020321 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K-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 M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624
Reason for recall
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Data sourced from openFDA. This site is unofficial and independent of the FDA.