Recall Z-0140-2027 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
| Date | Oct 9, 2026 (initiated Aug 13, 2026) |
| Status | Open, Classified |
| Reason | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| Root cause | Under Investigation by firm |
| Action | Beckton Dickenson (BD) notified consignees on about 08/13/2026 via mailed and emailed "URGENT: Medical Device Correction" letter. Clinical users were instructed to do the following: 1. Do not report CPO Ambler classification results generated from affected BD Phoenix CPO detect 6-well panels. 2. Do not release Ambler classification information from BD Phoenix panels on patient reports, laboratory information system reports, electronic health records, or other clinical reporting outputs. 3. CPO positive results, other resistance marker results, and any antimicrobial AST MIC and/or SIR resu |
| Quantity | 669,200 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181665 | BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN Becton, Dickinson and Company, Sep 21, 2018 |