Z-1847-2011

BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton...

Name: Z-1847-2011 BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton...
Creator: Becton Dickinson & Co.
Published: 2011-02-28
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-02-28 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD... on 2011-02-28. The reason FDA records is "In vitro diagnostic test kit is defective and may cause false positive or false negative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1847-2011
Status: Terminated
Initiated: 2011-02-28
Posted: 2011-03-30
Terminated: 2013-01-30
Recalling firm: Becton Dickinson & Co
Product: BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** The BD Phoenix Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: In vitro diagnostic test kit is defective and may cause false positive or false negative results.
FDA root cause: Mixed-up of materials/components
Action: BD Diagnostics Systems sent an Urgent Product Recall letter dated February 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinsue use of the affected product and discard any remaining packages. BD would issue replacements for the discarded material. Customers were instructed to complete the attached form whether or not they had any inventory remaining so that the firm may acknowledge receipt of this notification. Complete and fax the form to BD Regulatory Compliance to 410-316-4258. For further assistance contact BD Customer Service at 1-800-675-0908. For other inquiries, contact BD Technical Services at 1-800-638-8663.
Quantity in commerce: 377 cartons
Distribution: Worldwide Distribution - USA including AZ, CA, FL, GA, MA, MD, NC, NY, PA, TX, WA, WI, and WY and the countries of The product was distributed to medical facilities nationwide and to foreign consignees in Argentina, Brazil, Chile, and Mexico.
Product codes and lots: Lot 0223498 exp 8/31/2011

Product code LON

K033458Class IIBd Phoenix Automated Microbiology System - Confirmatory Esbl TestBecton, Dickinson & CO / cleared 2004-05-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)