BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differe

FDA device recall Z-1108-2012 · posted 2012-02-27 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..

Action taken

BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated January 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 packages. A form was attached for customers to complete and return via fax to: Attention: Regulatory Compliance at 410-316-4258. Contact the BD Technical Services Department at 1-800-638-8663 for questions regarding this recall.

Root cause

Process design

Status

Terminated

Product code

LKA

Quantity affected

132 bottles

Distribution

Worldwide Distribution-USA (nationwide) including the states of AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TX, VA, and WI, and the countries of Belgium, Ca

Date initiated

2012-01-11

Date posted

2012-02-27

Date terminated

2012-03-30

Location

Sparks, MD