FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: 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
- Recall number
- Z-0765-2021
- Recalling firm
- Becton Dickinson & Co.
- 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
- Status
- Terminated
- Initiated
- 2020-12-08
- Posted
- not on file
- Terminated
- 2023-10-03
- Reason
- 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
- Root cause
- Nonconforming Material/Component
- Action
- BD issued letters Urgent Medical Device Correction mailed beginning December 8, 2020 with FedEx tracking. Letter states reason for recall, health risk and action to take: 1.Share this product correction notification with all BD Phoenix" users within your facility network and post a copy near all BD Phoenix" instruments until the revised User Manual is available. 2. Respond to the product correction notification electronically by using the link BD.com/IDS-21-3976 or by returning to the attached Customer Response Form to the BD contact noted on the form so that BD may acknowledge your receipt of this notification per FDA requirements. Report any adverse health consequences experienced with the use of this product to BD. Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside of the United States, contact your local BD representative or distributor Actions Taken by BD: BD is updating the BD Phoenix" User Manual to provide additional guidance on use of the impacted panels and the manual is scheduled to be released by April 30, 2021. The revised manual will be accessible at bd.com/e-labeling. A BDXpert rule is also being developed to further assist customers on how to proceed with MIC readings for SXT. The BDXpert rule is set to be released by March 30, 2021 and will be included in the PUD update
- Quantity
- 31900 eaches
- Distribution
- Nationwide
- Lot, serial or model codes
- All unexpired lots UDI: 00382904484194
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LON
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28