Class 2 Device Recall BD Phoenix Panel NMIC312

• Date Initiated by Firm: August 13, 2026
• Date Posted: October 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0139-2027
• Recall Event ID: 99725
• 510(K)Number: K181665
• Product Classification: System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
• Product: BD Phoenix Panel NMIC-312. Catalog Number: 449082.
• Code Information: Catalog Number: 449082. UDI Numbers: (10)5324466(17)26 1116(30)0025(01)3 0382904490820, (10)5349874(17)26 1209(30)0025(01)3 0382904490820, (10)6008828(17)26 1226(30)0025(01)3 0382904490820, (10)5350977(17)26 1228(30)0025(01)3 0382904490820, (10)6028392(17)27 0120(30)0025(01)3 0382904490820, (10)6034513(17)27 0131(30)0025(01)3 0382904490820, (10)6042998(17)27 0202(30)0025(01)3 0382904490820, (10)6042021(17)27 0203(30)0025(01)3 0382904490820, (10)6056431(17)27 0217(30)0025(01)3 0382904490820, (10)6069033(17)27 0309(30)0025(01)3 0382904490820, (10)6083447(17)27 0327(30)0025(01)3 0382904490820, (10)6098295(17)27 0330(30)0025(01)3 0382904490820, (10)6104811(17)27 0412(30)0025(01)3 0382904490820, (10)6104042(17)27 0419(30)0025(01)3 0382904490820, (10)6118556(17)27 0421(30)0025(01)3 0382904490820, (10)6125526(17)27 0501(30)0025(01)3 0382904490820, (10)6128740(17)27 0503(30)0025(01)3 0382904490820, (10)6132650(17)27 0508(30)0025(01)3 0382904490820, (10)6132735(17)27 0510(30)0025(01)3 0382904490820, (10)6148198(17)27 0518(30)0025(01)3 0382904490820, (10)6148397(17)27 0524(30)0025(01)3 0382904490820, (10)6153088(17)27 0525(30)0025(01)3 0382904490820, (10)6153231(17)27 0526(30)0025(01)3 0382904490820, (10)6160397(17)27 0602(30)0025(01)3 0382904490820, (10)6160450(17)27 0605(30)0025(01)3 0382904490820, (10)6166259(17)27 0604(30)0025(01)3 0382904490820, (10)6166265(17)27 0606(30)0025(01)3 0382904490820, (10)6181978(17)27 0622(30)0025(01)3 0382904490820, (10)6181006(17)27 0623(30)0025(01)3 0382904490820, (10)6181015(17)27 0623(30)0025(01)3 0382904490820, (10)6181164(17)27 0626(30)0025(01)3 0382904490820, (10)6181151(17)27 0626(30)0025(01)3 0382904490820, (10)6181991(17)27 0622(30)0025(01)3 0382904490820, (10)6188614(17)27 0703(30)0025(01)3 0382904490820, (10)6188641(17)27 0703(30)0025(01)3 0382904490820, (10)6188683(17)27 0705(30)0025(01)3 0382904490820, (10)6188905(17)27 0710(30)0025(01)3 0382904490820, (10)6188922(17)27 0711(30)0025(01)3 0382904490820, (10)6195847(17)27 0713(30)0025(01)3 0382904490820, (10)6195877(17)27 0714(30)0025(01)3 0382904490820. Lot Numbers: 5324466, 5349874, 6008828, 5350977, 6028392, 6034513, 6042998, 6042021, 6056431, 6069033, 6083447, 6098295, 6104811, 6104042, 6118556, 6125526, 6128740, 6132650, 6132735, 6148198, 6148397, 6153088, 6153231, 6160397, 6160450, 6166259, 6166265, 6181978, 6181006, 6181015, 6181164, 6181151, 6181991, 6188614, 6188641, 6188683, 6188905, 6188922, 6195847, 6195877.
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: Matt Connor; 410-316-4221
• Manufacturer Reason for Recall: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
• FDA Determined 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: 553,625 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LON