Lower risk Medical device recall · FDA · Published December 8, 2020

BD Phoenix PMIC-107 IVD: Risk of false SXT resistance results with Staphylococcus aureus

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0761-2021Medical device Becton Dickinson ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/63700-bd-phoenix-pmic-107-ivd-risk-of-false-sxt-resistance.

Source Summary by GovInfoNow · govinfonow.com/recall/63700-bd-phoenix-pmic-107-ivd-risk-of-false-sxt-resistance · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0761-2021

Cite this page

“BD Phoenix PMIC-107 IVD: Risk of false SXT resistance results with Staphylococcus aureus.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63700-bd-phoenix-pmic-107-ivd-risk-of-false-sxt-resistance. Based on FDA recall #Z-0761-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0761-2021%22&limit=1).

Becton Dickinson & Co. recalled BD Phoenix PMIC-107 IVD devices nationwide due to potential false resistant results for S. aureus, according to the FDA on December 8, 2020. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Becton Dickinson
Product: BD Phoenix PMIC-107 IVD
Catalog Number: 448417
UDI: 00382904484170
Lots: All unexpired lots

The hazard

The recall addresses false resistant SXT results with S. aureus, which could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Recent brand recalls include a GasPak EZ Campy Pouch System recall for low CO2 levels on 2026-04-07, a BD Kiestra Isolate Suspension Cuvette Array recall for barcode errors on 2025-10-23, and a BD BACTEC 9120 Blood Culture System recall for unauthorized access risk on 2025-09-23. Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30 (2026-06-08), Biomerieux VITEK 2 AST-N447 Kit (2026-06-04), and Biomerieux VITEK 2 AST-N461 Test Kit (2026-07-24).

How to tell if you have this one

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.

Brand
Becton Dickinson
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
Z-0759-2021	BD Phoenix PMIC/ID-105: 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: 448605 (Discontinued); All unexpired lots UDI: 00382904486051	N/A
Z-0760-2021	BD Phoenix PMIC/ID-107: 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: 448607; All unexpired lots UDI: 00382904486075	69275 eaches
Z-0761-2021	BD Phoenix PMIC-107: 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: 448417; All unexpired lots UDI: 00382904484170	103475 eaches
Z-0762-2021	BD Phoenix PMIC/ID-108: 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: 448608; All unexpired lots UDI: 00382904486082	34825 eaches
Z-0763-2021	BD Phoenix PMIC-108: 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: 448418; All unexpired lots UDI: 00382904484187	60425 eaches
Z-0764-2021	BD Phoenix PMIC/ID-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: 448609; All unexpired lots UDI: 00382904486099	34650 eaches
Z-0765-2021	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; All unexpired lots UDI: 00382904484194	31900 eaches
Z-0766-2021	BD Phoenix PMIC-110: 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: 449036:; All unexpired lots UDI: 00382904490362	253575 eaches

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for catalog number 448417 on the BD Phoenix PMIC-107 IVD device.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Dec 8, 2020Firm started the recall
Dec 31, 2020FDA classified it Class II
Jan 6, 2021Published in FDA’s Enforcement Report
Oct 3, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this device safe to use?

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.

What does this mean for my treatment?

False results could lead to treatment issues, but the device is not dangerous. Healthcare providers should verify results with other tests if needed.

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Link to this recall

<a href="https://govinfonow.com/recall/63700-bd-phoenix-pmic-107-ivd-risk-of-false-sxt-resistance">BD Phoenix PMIC-107 IVD: Risk of false SXT resistance results with Staphylococcus aureus (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0761-2021 (December 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0761-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.