Becton Dickinson recalls BD Phoenix PMIC-109 IVD devices that may show false SXT resistance, risking ineffective antibiotic treatment for gram-positive bacteria infections.
BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
Becton Dickinson is recalling BD Phoenix PMIC-109 IVD devices that could give false results indicating sulfamethoxazole-trimethoprim (SXT) resistance. This might lead to using antibiotics that don't work well for infections caused by certain bacteria, potentially causing treatment failure.
The device may show false resistance to sulfameth:trimethoprim (SXT) in certain bacteria like Staphylococcus aureus. This could lead to using antibiotics that don't work properly, risking treatment failure for infections.
Healthcare professionals using BD Phoenix PMIC-109 IVD devices for bacterial testing are most at risk. Patients relying on these devices for infection treatment may face ineffective antibiotic regimens.
Check for the BD Phoenix PMIC-109 IVD device with catalog number 448419. All unexpired lots are affected, but the specific UDI is 00382904484194.
Verify the catalog number is 448419 and the UDI is 00382904484194.
The device may show false sulfamethoxazole-trimethoprim (SXT) resistance results, which could lead to ineffective antibiotic treatment for gram-positive bacteria infections.
The official recall notice does not specify a remedy or action for affected devices.
The recall indicates a potential risk of false results, but the device is not unsafe for normal use.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0765-2021 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0765-2021 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
