FDA-Device2026-10-21Class IIPROCESSING DEFECT
BD Phoenix Panel NMIC-312 recalled for quality control failures with Klebsiella pneumoniae
What this means
Becton Dickinson's Phoenix Panel NMIC-312 (Catalog Number 449082) may produce inaccurate results when testing Klebsiella pneumoniae using the CPO Ambler classification feature. This could cause quality control checks to fail undetected in clinical laboratories.
- If your lab uses affected lot numbers, contact Becton Dickinson for instructions.
- Review recent test results from affected panels for accuracy.
- Check the catalog number (449082) and lot number on your product against the FDA recall list.
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
553,625 units
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2027More Becton Dickinson recalls
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