BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
This recall has been terminated (originally issued July 24, 2013).
- Recall Initiated
- June 6, 2013
- Posted
- July 24, 2013
- Terminated
- September 3, 2013
- Recall Number
- Z-1805-2013
- Quantity
- 293 cartons
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Microbiological identification media may exhibit reduced levels of Vancomycin.
Distribution
Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Lot / Code Info
Lot 3078430 Exp 5/30/13
Root Cause
Nonconforming Material/Component
Action Taken
The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated June 2013 to Distributors by fax, US customers via letters by UPS and OUS BD sites via email and teleconference. The letter described the product, problem and actions to be taken. All customers were instructed to discontinue use of the listed product; discard any remaining packages, and complete and return the attached form, whether or not you have any inventory remaining, via Fax to: Attention: Regulatory Compliance, 410-316-4258. BD will issue replacements for the discarded material. It is not necessary to contact BD by telephone to receive replacements. If you have any questions, call 410-316-4000.