The Recall Desk
ModerateFDA (Devices)·Z-0739-2013·Announced 2013-02-06

Becton Dickinson Recalls BBL Fildes Enrichment Tubes for Growth Failure

Becton Dickinson is recalling BBL Fildes Enrichment tubes because they may fail to support the growth of Haemophilus species, potentially affecting laboratory test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional failure of the laboratory reagent that may lead to inaccurate test results, but there are no reports of direct patient injury or death.

Plain-English summary

Becton Dickinson & Co. is recalling BBL Fildes Enrichment, catalog number 211866, 10 tubes/pack. The product is a peptic digest of sheep blood intended to enrich media for the cultivation of various microorganisms, specifically to enhance the growth of fastidious organisms like Haemophilus influenzae.

The recall was initiated because the enrichment media may fail to support the growth of Haemophilus species. This defect could result in false-negative laboratory results for organisms requiring these specific growth factors.

The affected units were distributed worldwide, including nationwide in the USA and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore. The specific lots involved are 2079066 (EXP March 6, 2013), 2096375 (EXP March 22, 2013), 2216092 (EXP July 20, 2013), and 2227271 (EXP August 2, 2013). Laboratories and distributors should stop using the product and contact the manufacturer for instructions.

The recalled product

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 i
Affected units
11,710

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot/Exp 2079066/ EXP March 6
  • 2013 2096375/ EXP March 22
  • 2013 2216092/ EXP July 20
  • 2013 2227271/ EXP Auqust 2
  • 2013

Distribution

Distributed nationwide across the United States.