Z-1108-2012

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

Name: Z-1108-2012 BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in...
Creator: Becton Dickinson & Co.
Published: 2012-01-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-01-11 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on... on 2012-01-11. The reason FDA records is "Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1108-2012
Status: Terminated
Initiated: 2012-01-11
Posted: 2012-02-27
Terminated: 2012-03-30
Recalling firm: Becton Dickinson & Co
Product: BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
Product code: LKA Culture Media, Antimicrobial Susceptibility Test
Reason for recall: Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 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, Canada, Chile, China, Columbia, Costa Rica, Mexico, El Salvador, Ecuador, Japan, Manila, Singapore, Peru, Taiwan, and Venezuela.
Product codes and lots: Lot number 0204203 Exp. 3/31/14

Product code LKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)