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Recall Observatory FDA recall evidence

Device product

Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.

Z-0230-2015

October 16, 2014

Class III

Product summary

Firm
Biomerieux
Event
Event 69579
Status
Terminated
Classification
Class III
Quantity
652 devices
Official record key
device-enforcement:Z-0230-2015

Official wording

Reason: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.

Code information: Ref #537500, Lot #1003160540, Right Expiry date: 27-APR-2016

Distribution pattern: Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products have a wrong expiration date on their labeling, 5 years instead of 2 years.