Z-0570-2013Class II

BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton...

Name: Z-0570-2013 BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton...
Creator: Becton Dickinson & Co.
Published: 2012-11-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-11-06 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated... on 2012-11-06. FDA classified it as Class II and gives the reason as "An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria". 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-0570-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-06
Posted: 2012-12-19
Terminated: 2013-01-09
Recalling firm: Becton Dickinson & Co
Product: BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. If further assistance is needed regarding replacements please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
Quantity in commerce: 12,250 tests
Distribution: Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Product codes and lots: Lot number 2053373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0570-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0570-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code LON

K070809Class IIBd Phoenix Automated Microbiology System-Minocycline (Gp) 1-32 Ug/mlBecton, Dickinson & CO / cleared 2007-09-24

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)