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U.S. Department of Health and Human Services

Class 3 Device Recall Etest Ceftaroline (CPT32) US B100

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  Class 3 Device Recall Etest Ceftaroline (CPT32) US B100 see related information
Date Initiated by Firm October 16, 2014
Date Posted November 19, 2014
Recall Status1 Terminated 3 on November 30, 2017
Recall Number Z-0233-2015
Recall Event ID 69579
510(K)Number K121002  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product Etest¿ Ceftaroline (CPT32) US B100.

Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Code Information Ref #537548, Lot #1003202820, Right Expiry date: 27-APR-2016
Recalling Firm/
Manufacturer		 Biomerieux
69280 Marcy
Letoile France
For Additional Information Contact Ryan LeMelle
314-731-8582
Manufacturer Reason
for Recall		 The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
FDA Determined
Cause 2		 Labeling Change Control
Action Consignees of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioM¿rieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014.
Quantity in Commerce 652 devices
Distribution Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.
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 and Original Applicant = BIOMERIEUX, INC.
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