Device product
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.
Z-0739-2013
Product summary
- Event
- Event 64008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,710 tubes
- Official record key
device-enforcement:Z-0739-2013
Official wording
Reason: Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
Code information: Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013
Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.
Derived failure modes
-
Unknown
Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.