BD Phoenix PMIC-109 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-109 in vitro diagnostic devices because they may produce false resistant results for S. aureus, potentially affecting antibiotic treatment choices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, but the potential for reduced treatment effectiveness fits the 'High' severity criteria for theoretical harm without confirmed illness.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix PMIC-109 in vitro diagnostic (IVD) device, catalog number 448419. The device is intended for the rapid identification of gram-positive bacteria from pure culture, including Staphylococcus and Enterococcus genera. The recall covers 31,900 units distributed nationwide, including all unexpired lots with UDI 00382904484194.
The recall is due to a potential for false resistant results for Sulfamethoxazole-trimethoprim (SXT) when testing S. aureus. This error could lead to a loss of access to a preferred antibiotic regimen and a potential reduction in the effectiveness of treating the infection.
Healthcare facilities and laboratories that possess this device should stop using it and contact Becton Dickinson for instructions on return or replacement. Consumers are not directly affected as this is a professional in vitro diagnostic product.
The recalled product
- Product
- BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448419
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 31,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All unexpired lots UDI: 00382904484194
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
- HighAutomated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBlood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighBD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results
FDA (Devices) · 2012-12-26
- HighBD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures
FDA (Devices) · 2017-12-06
- HighBD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results
FDA (Devices) · 2014-02-05
- HighBD BACTEC FX Diagnostic Instrument Recalled for False Negative Results
FDA (Devices) · 2014-02-05
- HighBD MAX Enteric Bacterial Panel Recalled for False Negative Results
FDA (Devices) · 2019-03-13
- HighBD Phoenix diagnostic systems may misidentify E. coli in clinical samples
FDA (Devices) · 2024-10-02