Becton Dickinson recalls BD Phoenix PMIC/ID-105 IVD devices that may produce false SXT resistance results with Staphylococcus aureus, risking ineffective antibiotic treatment. Affected units include all unexpired lots with catalog number 44860:05.
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/ID-105 devices that may give false results indicating sulfamethoxazole-trimethoprim (SXT) resistance in Staphylococcus aureus. This could lead to treatment failure if the false result causes doctors to avoid effective antibiotics. The recall affects all unexpired lots of this device.
The device may produce false results showing SXT resistance in Staphylococcus aureus. This could lead to doctors avoiding effective antibiotics, potentially causing treatment failure. The risk is not immediate but depends on how the results are interpreted.
Healthcare professionals using BD Phoenix PMIC/ID-105 devices for bacterial identification are most at risk. The recall applies to all unexpired lots of this device.
Check for the catalog number 448605 on the device label. The device is intended for in vitro rapid identification of gram-positive bacteria. All unexpired lots are affected.
Look for the catalog number 448605 on the device label to confirm if it is affected.
The device may produce false results that could lead to treatment failure, so it is recommended to stop using it until the recall is addressed.
Check the device label for catalog number 448605. If it matches, stop using it and contact Becton Dickinson for further instructions.
The affected device has catalog number 448605 and is intended for in vitro rapid identification of gram-positive bacteria.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0759-2021 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0759-2021 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.