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.
This recall has been terminated (originally issued March 23, 2012).
- Recall Initiated
- February 20, 2012
- Posted
- March 23, 2012
- Terminated
- June 18, 2012
- Recall Number
- Z-1282-2012
- Quantity
- 6930 tubes
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.
Lot / Code Info
Lot 1186346, exp June 22, 2012 Lot 1229762, exp August 03, 2012
Root Cause
Nonconforming Material/Component
Action Taken
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.