Home / Recalls / BioMerieux SA / Z-1226-2017

Z-1226-2017 Class II Terminated

Recalled by BioMerieux SA — Marcy L'Etoile, N/A

Recall Details

Product Type
Devices
Report Date
March 1, 2017
Initiation Date
January 18, 2017
Termination Date
January 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,160 units

Product Description

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

Reason for Recall

Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

Distribution Pattern

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

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

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