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.
FDA Recall Z-1322-2012 · Posted 2012-03-27
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeMDB
Date Initiated2012-01-30
Date Terminated2012-04-02
Product Quantity3900 tubes
Reason for Recall
Media fails to perform as intended with quality control organism Mycobacterium kansasii.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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