Device recall

BD Phoenix Panel NMIC-306. Catalog Number: 449292.

FDA recall source

Recall number

Z-0140-2027

Event id

99725

Status

Ongoing

FDA classification

Class II

Recalling firm

Becton Dickinson & Co.

Report date

Oct 21, 2026

Posted

Oct 9, 2026

Initiated

Aug 13, 2026

Center classification date

Oct 9, 2026

Product code

LON

Device type

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Reason

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

Root cause

Under Investigation by firm

Quantity

669,200 units

Code info

Catalog Number: 449292. UDI Numbers: (10)5301934(17)26 1102(30)0025(01)3 0382904492923, (10)5301046(17)26 1107(30)0025(01)3 0382904492923, (10)5301019(17)26 1105(30)0025(01)3 0382904492923, (10)5301058(17)26 1108(30)0025(01)3 0382904492923, (10)5301088(17)26 1109(30)0025(01)3 0382904492923, (10)5324448(17)26 1111(30)0025(01)3 0382904492923, (10)5325592(17)26 1122(30)0025(01)3 0382904492923, (10)5336528(17)26 1125(30)0025(01)3 0382904492923, (10)5336554(17)26 1130(30)0025(01)3 0382904492923, (10)5336667(17)26 1203(30)0025(01)3 0382904492923, (10)5336716(17)26 1206(30)0025(01)3 0382904492923, (10)5343520(17)26 1209(30)0025(01)3 0382904492923, (10)5343522(17)26 1221(30)0025(01)3 0382904492923, (10)5350942(17)26 1226(30)0025(01)3 0382904492923, (10)5350876(17)26 1223(30)0025(01)3 0382904492923, (10)5350972(17)26 1228(30)0025(01)3 0382904492923, (10)6006439(17)26 1231(30)0025(01)3 0382904492923, (10)6006497(17)27 0104(30)0025(01)3 0382904492923, (10)6006475(17)27 0103(30)0025(01)3 0382904492923, (10)6013345(17)27 0111(30)0025(01)3 0382904492923, (10)6013300(17)27 0109(30)0025(01)3 0382904492923, (10)6013963(17)27 0118(30)0025(01)3 0382904492923, (10)6013924(17)27 0117(30)0025(01)3 0382904492923, (10)6034519(17)27 0131(30)0025(01)3 0382904492923, (10)6042012(17)27 0203(30)0025(01)3 0382904492923, (10)6042040(17)27 0204(30)0025(01)3 0382904492923, (10)6042153(17)27 0208(30)0025(01)3 0382904492923, (10)6069030(17)27 0309(30)0025(01)3 0382904492923, (10)6082661(17)27 0313(30)0025(01)3 0382904492923, (10)6098326(17)27 0331(30)0025(01)3 0382904492923, (10)6098427(17)27 0405(30)0025(01)3 0382904492923, (10)6104765(17)27 0411(30)0025(01)3 0382904492923, (10)6125411(17)27 0427(30)0025(01)3 0382904492923, (10)6128662(17)27 0430(30)0025(01)3 0382904492923, (10)6138197(17)27 0505(30)0025(01)3 0382904492923, (10)6148207(17)27 0519(30)0025(01)3 0382904492923, (10)6148231(17)27 0520(30)0025(01)3 0382904492923. Lot Numbers: 5301934, 5301046, 5301019, 5301058, 5301088, 5324448, 5325592, 5336528, 5336554, 5336667, 5336716, 5343520, 5343522, 5350942, 5350876, 5350972, 6006439, 6006497, 6006475, 6013345, 6013300, 6013963, 6013924, 6034519, 6042012, 6042040, 6042153, 6069030, 6082661, 6098326, 6098427, 6104765, 6125411, 6128662, 6138197, 6148207, 6148231.

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K181665

Location

Sparks, MD, United States