| Class 1 Device Recall Etest |  |
Date Initiated by Firm | November 19, 2015 |
Date Posted | December 23, 2015 |
Recall Status1 |
Terminated 3 on June 19, 2017 |
Recall Number | Z-0439-2016 |
Recall Event ID |
72755 |
510(K)Number | K953223 |
Product Classification |
Manual antimicrobial susceptibility test systems - Product Code JWY
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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. 412434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and 1001936360. |
Recalling Firm/ Manufacturer |
Biomerieux 69280 Marcy Letoile France
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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 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 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWY
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