FDA-Device2026-10-21Class IIPROCESSING DEFECT
BD Phoenix Panel NMIC-306 recalled for quality control failures with Klebsiella pneumoniae testing
What this means
Becton Dickinson's Phoenix Panel NMIC-306 microbiology testing panel may produce inaccurate results when using the CPO Ambler classification feature to identify Klebsiella pneumoniae bacteria. This quality control failure could lead to misidentification of the organism during laboratory testing.
- If your laboratory uses affected lot numbers, contact BD customer support for guidance.
- Review results from affected panels, particularly those testing Klebsiella pneumoniae with the CPO Ambler feature.
- Check the lot number on your panels against the list provided in the recall notice.
The agency's original wording
Hazard
Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
669,200 units
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0140-2027More Becton Dickinson recalls
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