Z-1322-2012

BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes

Name: Z-1322-2012 BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes
Creator: Becton Dickinson & Co.
Published: 2012-01-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-01-30 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the... on 2012-01-30. The reason FDA records is "Media fails to perform as intended with quality control organism Mycobacterium kansasii". 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-1322-2012
Status: Terminated
Initiated: 2012-01-30
Posted: 2012-03-27
Terminated: 2012-04-02
Recalling firm: Becton Dickinson & Co
Product: BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as deeps is used for the semi-quantitative catalase test as an aid to the classification of mycobacteria.
Product code: MDB System, Blood Culturing
Reason for recall: Media fails to perform as intended with quality control organism Mycobacterium kansasii.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated January 2012 to Ex-US BD sites via email and its customers via UPS ground shipment on 1/30/12. The letter identified the product, the problem and the action to be taken. The customers were instructed to discontinue use of the recalled lot numbers and discard any remaining packages. Customers were also instructed to complete and return the attached form whether or not they had any inventory remaining via fax to: BD Regulatory Compliance at 410-316-4285. The letter also informed the customers that BD has decided to discontinue this product. If further assistance is needed regarding credit, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
Quantity in commerce: 3900 tubes
Distribution: Worldwide Distribution - USA (nationwide) including states of: AL, CA, CT, IA, IL, KY, LA, MD, MI, MN, NC, NJ, NY, OH, PA, TN, VA, WA, and WV; and countries of : Belgium and Singapore.
Product codes and lots: Catalog #221257, Lot 0091498 Exp. 10/6/11, Lot 0224698 Exp. 2/16/12, Lot 0301803 Exp. 5/3/1112, Lot 1055386 Exp. 8/30/12, Lot 1167837 Exp. 12/20/12

Product code MDB

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)