FDA (Devices) recall action 86963

Becton Dickinson & Co. recalled 8 products on 2021-01-06

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2021-01-06
Critical: 0
Units: 588,125

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

SevereFDA (Devices)··2021-01-06
BD Phoenix PMIC-110 Recalled for False SXT Resistance Results
Becton Dickinson & Co. is recalling BD Phoenix PMIC-110 IVDs due to false resistant SXT results with S. aureus, which could impact antibiotic treatment.
Product
BD Phoenix PMIC-110: 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: 449036:
Category
Distribution
0 states
HighFDA (Devices)··2021-01-06
BD Phoenix PMIC/ID-109 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC/ID-109 because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-109: 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: 448609
Category
Distribution
0 states
HighFDA (Devices)··2021-01-06
BD Phoenix PMIC/ID-105 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-105 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-105: 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: 448605 (Discontinued)
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0 states
SevereFDA (Devices)··2021-01-06
BD Phoenix PMIC-107 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-107 IVDs because false resistant results for S. aureus could lead to reduced treatment effectiveness.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2021-01-06
BD Phoenix PMIC-108 Recalled for False SXT Resistance Results
Becton Dickinson & Co. is recalling BD Phoenix PMIC-108 IVDs because false resistant results for S. aureus could lead to ineffective antibiotic treatment.
Product
BD 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
Category
Distribution
0 states
HighFDA (Devices)··2021-01-06
BD Phoenix PMIC-109 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-109 in vitro diagnostic devices because they may produce false resistant results for S. aureus, potentially affecting antibiotic treatment choices.
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 Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448419
Category
Distribution
0 states
HighFDA (Devices)··2021-01-06
BD Phoenix PMIC/ID-108 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-108 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
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
Category
Distribution
0 states
HighFDA (Devices)··2021-01-06
BD Phoenix PMIC/ID-107 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-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: 448607
Category
Distribution
0 states