Etest Ceftaroline (CPT32) US B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
FDA Recall Z-0232-2015 · Posted 2014-11-19
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Recalling FirmBiomerieux
Recall StatusTerminated
Product CodeJWY
Date Initiated2014-10-16
Date Terminated2017-11-30
Product Quantity652 devices
Reason for Recall
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Firm Action
Consignees of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioMrieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014.
Root Cause
Labeling Change Control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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