Becton Dickinson recalls BD Phoenix PMIC-107 IVD devices that may give false SXT resistance results with Staphy: could lead to treatment issues. Affected units have catalog number 448417.
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-107 IVD devices that might show false resistance to sulfamethoxazole-trimethoprim (SXT) for Staphylococcus aureus. This could mean patients don't get the right antibiotic treatment. The recall covers all unexpired lots with catalog number 448417.
The device may incorrectly indicate SXT resistance in Staphylococcus aureus, which could lead to using the wrong antibiotic. This might cause treatment failure or reduced effectiveness of the antibiotic regimen.
Healthcare professionals using BD Phoenix PMIC-107 IVD devices for bacterial identification are most at risk. Patients relying on these devices for infection treatment could face treatment issues if false results occur.
Check for catalog number 448417 on the device label. The product is intended for in vitro rapid identification of gram-positive bacteria from pure culture.
Look for catalog number 448417 on the BD Phoenix PMIC-107 IVD device.
The recall states the device may give false results, but it is not unsafe. Users should check for the catalog number and follow the recall instructions.
False results could lead to treatment issues, but the device is not dangerous. Healthcare providers should verify results with other tests if needed.
Look for catalog number 448417 on the device label. The product is intended for in vitro rapid identification of gram-positive bacteria from pure culture.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0761-2021 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0761-2021 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.
