—#184932

Product

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

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: All unexpired lots UDI: 00382904486082

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2020-12-08
Terminated: 2023-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184932. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.