Z-1398-2024Class II

BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System)...

Name: Z-1398-2024 BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System)...
Creator: Becton Dickinson & Co.
Published: 2024-02-29
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-02-29 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells... on 2024-02-29. FDA classified it as Class II and gives the reason as "Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1398-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-29
Posted: 2024-03-29
Recalling firm: Becton Dickinson & Co
Product: BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
FDA root cause: Under Investigation by firm
Action: BD issued URGENT: Medical Device Product Correction Product Removal letter on 2/29/24 via courier service via tracked letter and/or e-mail. Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood. 3. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. BD will issue product replacements following receipt of the completed Customer Response Form. Contact: North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected] Product Advisory, Recall Questions, Product Complaints, Technical Questions
Quantity in commerce: 11,800 eaches
Distribution: Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.
Product codes and lots: UDI-DI: (10) 3318700 (17)241107 (30)0025 (01) 30382904492923 Lot Number: 3318700 Exp. Date: 07-NOV-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1398-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1398-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29
Z-1399-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-03-29

Product code LON

K132674Class IIBd Phoenix Automated Microbiology System- Meropenem (0.125-32 Ug/ml)Becton, Dickinson and Company / cleared 2013-12-27

MDM coverage of this record lists here, newest first.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)