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
Reported: January 6, 2021 Initiated: December 8, 2020 #Z-0765-2021
Product Description
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
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
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 31900 eaches
- Distribution
- Nationwide
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Becton Dickinson & Co.. Units affected: 31900 eaches.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2021. Severity: Moderate. Recall number: Z-0765-2021.
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