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Becton Dickinson & Co. Recall 86963

Description: BD Phoenix PMIC-107: 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: 448417

Becton Dickinson & Co. Recall 86963 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0761-2021
Event ID86963
Event DescriptionBD Phoenix PMIC-107: 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: 448417
Product TypeDevices
DistributionNationwide
Quantity103475 eaches
Recall ReasonBD 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
Device Classification20210106
Device Code InfoAll unexpired lots UDI: 00382904484170
Center Classification Date20201231
Recall Initiation Date20201208
Recalling FirmBecton Dickinson & Co.
Initial Notification Letter
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