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Terminated

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

FDA Recall Z-1226-2017 · Posted None

Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodeJWY
Date Initiated2017-01-18
Date Terminated2020-01-30
Product Quantity7,160 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990722ETEST FOR CEFUROXIMEAb Biodisk · 1999-04-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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