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Recall Observatory FDA recall evidence

Device product

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

Z-1947-2015

June 12, 2015

Class II

Product summary

Firm
BioMerieux SA
Event
Event 71475
Status
Terminated
Classification
Class II
Quantity
674
Official record key
device-enforcement:Z-1947-2015

Official wording

Reason: QC results were out of range resulting in false resistant strains.

Code information: 1002774320, 1002377890, 1002590470, 1002775330, 1002379610

Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    QC results were out of range resulting in false resistant strains.