Recall Z-0139-2027

Recall number
Z-0139-2027
Event number
99725
Firm
Becton Dickinson & Co.
Firm FEI
1119779
Product code
LON
Status
Open, Classified
Initiated
2026-08-13
Posted
2026-10-09
Root cause
Under Investigation by firm
510(k) numbers
K181665, K103752, K043389, K020209, K042932, K091899, K033889, K051478, K222430, K020173, K031410, K020871, K042963, K023541, K191766, K070346, K213931, K063492, K061867, K040106, K050555, K032738, K043458, K060214, K223478, K050982, K250447, K033362, K260282, K142170

Product#

BD Phoenix Panel NMIC-312. Catalog Number: 449082.

Reason for Recall#

Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.