BD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results
Becton Dickinson is recalling 12,250 BD Phoenix PMIC-108 panels because they may produce false intermediate or resistant antibiotic susceptibility results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate clinical test results (false resistant/intermediate), which poses a risk of harm to patients through potential treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling 12,250 units of BD Phoenix PMIC-108 Panels, Catalog number 448418, Lot number 2053373. These panels are used with the BD Phoenix Automated Microbiology system for the rapid identification and antimicrobial susceptibility testing of clinically significant bacteria.
The recall was initiated because the test kits may produce false intermediate or false resistant results when testing clinically significant bacteria. This could lead to inaccurate clinical data regarding antibiotic susceptibility.
The affected products were distributed nationwide in the United States, including the states of Arkansas, California, Kentucky, Oklahoma, Rhode Island, Wisconsin, and Wyoming. Users should stop using the affected panels and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clini
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 12,250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 2053373
Distribution
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