BD Phoenix Panel NMIC-312. Catalog Number: 449082 recallZ-0139-2027 · Becton Dickinson & Co. · initiated Aug 13, 2026

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-0139-2027

Recall class

Not yet classified by the FDA

Status

Open, Classified

Initiated by the company

Aug 13, 2026

Posted by the FDA

Oct 9, 2026

Recalling firm

Becton Dickinson & Co.

Quantity

553,625 units

Product code

LON

FDA submissions

K181665

Distribution

US Nationwide distribution.

Product description

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

Other devices under the same FDA submission

2 devices cleared under K181665 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• NMIC-312 449082

  Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
  64 reports
• NMIC/ID-313 449083

  Becton, Dickinson And Company · SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
  24 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99725).

• Z-0140-2027 · Open, Classified
  BD Phoenix Panel NMIC-306. Catalog Number: 449292.