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U.S. Department of Health and Human Services

Class 2 Device Recall ETEST IMIPENEM RELEBACTAM

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  Class 2 Device Recall ETEST IMIPENEM RELEBACTAM see related information
Date Initiated by Firm June 24, 2021
Create Date August 06, 2021
Recall Status1 Open3, Classified
Recall Number Z-2226-2021
Recall Event ID 88242
510(K)Number K191953  
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Code Information Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and  Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Clinical Customer Support
800-682-2666
Manufacturer Reason
for Recall		 Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to: - Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST¿ IMIPENEM RELEBACTAM  ref. 420925 and 420927 - Among tests previously performed, identify any possible false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant.
Quantity in Commerce 1,431
Distribution Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWY and Original Applicant = BioMerieux SA
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