Z-1282-2012

Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic...

Name: Z-1282-2012 Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic...
Creator: Becton Dickinson & Co.
Published: 2012-02-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-02-20 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD... on 2012-02-20. The reason FDA records is "In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended". 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-1282-2012
Status: Terminated
Initiated: 2012-02-20
Posted: 2012-03-23
Terminated: 2012-06-18
Recalling firm: Becton Dickinson & Co
Product: Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.
Product code: JSC Culture Media, General Nutrient Broth
Reason for recall: In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Becton Dickinson (BD) sent an "URGENT PRODUCT RECALL" letter dated February 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining affected product. BD will issue replacements for the discarded product. Additionally, an Acknowledgment Form was attached for customers to complete and return to the firm via fax to 410-316-4258. Contact BD Technical Services Department for questions regarding this notice.
Quantity in commerce: 6930 tubes
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.
Product codes and lots: Lot 1186346, exp June 22, 2012 Lot 1229762, exp August 03, 2012

Product code JSC

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)