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.
FDA Recall Z-1282-2012 · Posted 2012-03-23
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJSC
Date Initiated2012-02-20
Date Terminated2012-06-18
Product Quantity6930 tubes
Reason for Recall
In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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