Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 25

FDA device recall Z-1282-2012 · posted 2012-03-23 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JSC

Quantity affected

6930 tubes

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.

Date initiated

2012-02-20

Date posted

2012-03-23

Date terminated

2012-06-18

Location

Sparks, MD