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
Reported: March 1, 2017 Initiated: January 18, 2017 #Z-1226-2017
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.
Details
- Recalling Firm
- BioMerieux SA
- Units Affected
- 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
- Location
- Marcy L'Etoile, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by BioMerieux SA. Units affected: 7,160 units.
Why was this product recalled? ▼
Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1226-2017.
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