Z-0523-2013Class II

BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part...

Name: Z-0523-2013 BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part...
Creator: Becton Dickinson & Co.
Published: 2012-10-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-10-22 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle... on 2012-10-22. FDA classified it as Class II and gives the reason as "In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens". 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-0523-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-22
Posted: 2012-12-13
Terminated: 2013-01-24
Recalling firm: Becton Dickinson & Co
Product: BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Product code: GRO Antisera, Fluorescent, All Types, Hemophilus Spp.
Reason for recall: In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: BD Diagnostic Systems sent an Urgent Product Recall letter dated October 22, 2012, to all affected customers.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue distribution and discard affected inventory for credit. . Customers were requested to return a response form by fax to 410-316-4258. For questions customers were instructed to contact BD Customer Service Department at 1-800-638-8663. For assistance with replacements, customers were instructed to call 1-800-675-0908. For questions regarding this recall call 410-316-4258.
Quantity in commerce: 650 vials
Distribution: Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Product codes and lots: Lot number 2089253

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0523-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0523-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-13

Product code GRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)