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Class 2 Device Recall ETEST Cefuroxime |
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Date Initiated by Firm |
January 18, 2017 |
Create Date |
February 21, 2017 |
Recall Status1 |
Terminated 3 on January 30, 2020 |
Recall Number |
Z-1226-2017 |
Recall Event ID |
76329 |
510(K)Number |
K990722
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Product Classification |
Manual antimicrobial susceptibility test systems - Product Code JWY
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Product |
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria |
Code Information |
REF 412304 - 1004497830; REF 412305 - 1002884720, 1003028270, 1003075500, 1003383650, 1004018820, 1004497810, 1005161160; REF 506918 - 1002884980, 1003028290, 1003075850, 1003385930, 1003396150, 1004022170, 1004498100, 1005161470; REF 506958 - 1002885010, 1003075540, 103396550, 1004019050, 1004501930, 1005161480 |
Recalling Firm/ Manufacturer |
BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
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For Additional Information Contact |
Tiffany Mentzel 919-620-3396
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Manufacturer Reason for Recall |
Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
BioMerieux sent an Urgent Field Safety Notice electronically on 1/18/2017. The notice included instructions and recommendations for users of the product. The notice included an acknowledgment form to be returned. Customers with questions were instructed to contact their BioMerieux representative. For questions regarding this recall call 919-620-3396. |
Quantity in Commerce |
7,160 units |
Distribution |
Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, Costa Rica, Croatia, Czech Republic, Ecuador, Estonia, France, Greece, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay, and Vietnam |
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 and Original Applicant = AB BIODISK
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