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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix PMIC108

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 Class 2 Device Recall BD Phoenix PMIC108see related information
Date Initiated by FirmDecember 08, 2020
Create DateDecember 31, 2020
Recall Status1 Terminated 3 on October 03, 2023
Recall NumberZ-0763-2021
Recall Event ID 86963
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
ProductBD 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
Code Information All unexpired lots UDI: 00382904484187
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactBD Customer/ Technical Support
800-638-8663
Manufacturer Reason
for 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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBD 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 in Commerce60425 eaches
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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