Class 2 Device Recall Etest CEFOTAXIME CT 256

• Date Initiated by Firm: June 12, 2015
• Date Posted: July 01, 2015
• Recall Status: Terminated on August 01, 2017
• Recall Number: Z-1947-2015
• Recall Event ID: 71475
• 510(K)Number: K981137
• Product Classification: Manual antimicrobial susceptibility test systems - Product Code JWY
• Product: Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
• Code Information: 1002774320, 1002377890, 1002590470, 1002775330, 1002379610
• Recalling Firm/ Manufacturer: BioMerieux SA; Chemin De L'Orme; Marcy L'Etoile France
• For Additional Information Contact: Ryan LeMelle; 919-620-2599
• Manufacturer Reason for Recall: QC results were out of range resulting in false resistant strains.
• FDA Determined Cause: Process control
• Action: BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required actions: Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. Discontinue using and discard any remaining inventory of Etest CEFOTAXIME CT 256 lots reported in table 1. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement. bioMrieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.
• Quantity in Commerce: 674
• Distribution: Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWY