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U.S. Department of Health and Human Services

Class 1 Device Recall Etest

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 Class 1 Device Recall Etestsee related information
Date Initiated by FirmNovember 19, 2015
Date PostedDecember 23, 2015
Recall Status1 Terminated 3 on June 19, 2017
Recall NumberZ-0439-2016
Recall Event ID 72755
510(K)NumberK953223 
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
ProductEtest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Code Information Ref. 412434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and  1001936360. 
Recalling Firm/
Manufacturer		 Biomerieux
69280 Marcy
Letoile France
For Additional Information ContactRyan LeMelle
314-731-8582
Manufacturer Reason
for Recall		Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
FDA Determined
Cause 2		Process change control
ActionConsignees (Subsidiaries and Distributors) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on November 24th, 2015. Additionally, the bioMrieux United States subsidiary notified US consignees (distributors/end-users) of the FSCA notification via FedEx on December 2nd, 2015.
Quantity in Commerce5458 units
DistributionWorldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWY
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