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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 Etest see related information
Date Posted December 23, 2015
Recall Status1 Open
Recall Number Z-0439-2016
Recall Event ID 72755
510(K)Number K953223 
Product Classification Manual antimicrobial susceptibility test systems - Product Code JWY
Product Etest¿ 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. 4122434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and
1001936360.
Recalling Firm/
Manufacturer
Biomerieux
69280 Marcy
Letoile France
For Additional Information Contact Ryan 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
Action Consignees (Subsidiaries and Distributors) of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on November 24th, 2015. Additionally, the bioM¿rieux United States subsidiary notified US consignees (distributors/end-users) of the FSCA notification via FedEx on December 2nd, 2015.
Quantity in Commerce 5458 units
Distribution Worldwide 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 Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWY and Original Applicant = AB BIODISK
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