Z-0140-2027

BD Phoenix Panel NMIC-306. Catalog Number: 449292

Name: Z-0140-2027 BD Phoenix Panel NMIC-306. Catalog Number: 449292
Creator: Becton Dickinson & Co.
Published: 2026-08-13
License: https://open.fda.gov/license/

Becton Dickinson & Co. / initiated 2026-08-13 / Open, Classified

FDA source

Recall record

Recall number: Z-0140-2027
Status: Open, Classified
Initiated: 2026-08-13
Posted: 2026-10-09
Recalling firm: Becton Dickinson & Co.
Product: BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
FDA root cause: Under Investigation by firm
Action: Beckton Dickenson (BD) notified consignees on about 08/13/2026 via mailed and emailed "URGENT: Medical Device Correction" letter. Clinical users were instructed to do the following: 1. Do not report CPO Ambler classification results generated from affected BD Phoenix CPO detect 6-well panels. 2. Do not release Ambler classification information from BD Phoenix panels on patient reports, laboratory information system reports, electronic health records, or other clinical reporting outputs. 3. CPO positive results, other resistance marker results, and any antimicrobial AST MIC and/or SIR result from the BD Phoenix panels are unaffected and may still be reported according to routine laboratory reporting practice. 4. Confirmatory testing to verify appropriate Ambler Classification should be determined and performed in accordance with established laboratory procedures. 5. There are no recommendations regarding results review or sample retesting. Customers were instructed to ensure the contents of the notification are read and understood, share and post the customer letter within each facility network, forward to any customers to whom product may have been distributed to. Additionally, customers were instructed to complete and return the provided Customer Response Form. BD is investigating the root cause and will implement appropriate corrective actions to rectify this issue as soon as possible. **UPDATE 09/02/2026: Firm expanded recall and sent updated notification to include an additional product code. Instructions remained the same.
Quantity in commerce: 669,200 units
Distribution: US Nationwide distribution.
Product codes and lots: 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.

Product code LON

K181665Class IIBD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company / cleared 2018-09-21

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)