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Terminated

BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.

FDA Recall Z-0739-2013 · Posted 2013-01-25

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJSC
Date Initiated2012-12-10
Date Terminated2013-07-01
Product Quantity11,710 tubes

Reason for Recall

Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.

Firm Action

Becton Dickinson sent an Urgent Product Recall letter dated December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to discontinue use and discard any remaining product for replacement. Customers were also advised that due to an anticipated extended delay for the availability of Fildes Enrichment, BD will substitute DIFCO" Supplement B with Reconstituting Fluid as the replacement product. Customers were advised to ensure that this replacement product is appropriately validated in accordance with their laboratory's procedures. Customers with questions should contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4000.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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