BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul,

FDA device recall Z-2319-2012 · posted 2012-09-06 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Leakage in Cepheid SmartCycler reaction tubes.

Action taken

BD Diagnostic Systems issued an Urgent Product Recall letter via UPS overnight delivery on May 22, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue use and discard any affected product. BD would send replacement tubes for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance FAX: 410-316-4258 Email: RegulatoryComplianceFax@bd.com If further assistance is needed, customers should contact BD Technical Services Department at 1-800-838-8663. For questions regarding this recall call 410-316-4054.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LLH

Quantity affected

32 kits

Distribution

Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.

Date initiated

2012-05-22

Date posted

2012-09-06

Date terminated

2012-11-02

Location

Sparks, MD

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