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BD Phoenix PMIC/ID-108: IVD is intended for the in vitro… recallZ-0762-2021 · Becton Dickinson & Co. · initiated Dec 8, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-0762-2021
Status
Terminated
Initiated by the company
Dec 8, 2020
Recalling firm
Becton Dickinson & Co.
Quantity
34825 eaches
Product code
LON
Distribution
Nationwide

Product description

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

Code information (models, lots, serial numbers)

All unexpired lots UDI: 00382904486082

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 86963).

Sources and updates

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