Z-1657-2012

Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology...

Name: Z-1657-2012 Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology...
Creator: Becton Dickinson & Co.
Published: 2012-04-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-04-10 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID... on 2012-04-10. The reason FDA records is "BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1657-2012
Status: Terminated
Initiated: 2012-04-10
Posted: 2012-05-24
Terminated: 2013-08-08
Recalling firm: Becton Dickinson & Co
Product: Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.
Quantity in commerce: 3,454,993 total products (U.S.)
Distribution: Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT ,DC ,FL , GA, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, AND WY. and the countries of Canada, Australia, Philippines, Thailand, Malaysia, India, New Zealand, Belgium, Singapore, Japan, Taiwan, China, Chile, Colombia, Korea, Brazil and Venezuela.
Product codes and lots: Software versions: 5.55R, 5.66A, 5.70A, 5.75A, 5.83A, and 6.01A

Product code LON

K030677Class IIBd Phoenix Automated Microbiology System-Vancomycin Gram PositiveBecton, Dickinson & CO / cleared 2003-04-01

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)