FDAClass IIJanuary 6, 2021

BD Phoenix" PMIC-109: IVD is intended for the in vitro recall

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…

Why was BD Phoenix" PMIC-109: IVD is intended for the in vitro 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All unexpired lots UDI: 00382904484194

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…
Recalling firm
Becton Dickinson & Co.
Quantity
31900 eaches
Distribution
Nationwide
Recall date
January 6, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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