Z-0366-2011

BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton...

Name: Z-0366-2011 BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton...
Creator: Becton Dickinson & Co.
Published: 2010-05-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-05-14 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Co. began a recall of BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152... on 2010-05-14. The reason FDA records is "The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0366-2011
Status: Terminated
Initiated: 2010-05-14
Posted: 2010-11-15
Terminated: 2010-11-29
Recalling firm: Becton Dickinson & Co
Product: BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded. For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.
Quantity in commerce: 1675 units
Distribution: Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.
Product codes and lots: Lot 0083198 Exp 03/31/2011

Product code LON

K021954Class IIBd Phoenix Automated Microbiology System-Clindamycin 0.125-8.0Mcg/mlBecton, Dickinson & CO / cleared 2002-08-01

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)