Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM), 의 리콜

Recall

77609

Class 2

Z-0196-2018

2017-05-22

Terminated

United States

2018-02-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156766

Listeria monocytogenes contamination of non-sterile plated media.

BD Life Sciences initiated communication with distributors by issuing Urgent Product Recall and Customer Response Form notices via UPS mailing on May 22, 2017. General customers were issued Urgent Product Recall and Customer Response Form letters via UPS mailing on May 25, 2017. - General customers were advised to visually inspect all non-sterile prepared media prior to use to assure that there is no surface and/or subsurface contamination. If the customer observes a plate without evidence of microbial contamination that grows Listeria, please consult the clinician to make sure this result is consistent with the patient's clinical presentation. - Distributors were advised to discontinue distribution of the lots and to discard any remaining inventory. Customers are advised to complete and return the enclosed response form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or email to BDRC2@bd.com **Note to Distributors: Please provide BD Regulatory Compliance an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so they can be notified. Mail or fax to: BD Regulatory Compliance 7 Loveton Circle Mail Stop 640, Sparks, MD 21152 Fax: 410-316-4258; Email: BDRC2@bd.com. Customers with questions please contact BD Support at 1-800-638-8663. For customers outside of the U.S., contact your local BD representative or distributor. For questions regarding this recall call 410-316-4000.