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.
This recall has been terminated (originally issued November 19, 2014).
- Recall Initiated
- October 16, 2014
- Posted
- November 19, 2014
- Terminated
- November 30, 2017
- Recall Number
- Z-0232-2015
- Quantity
- 652 devices
- Official Source
- View on FDA website ↗
Reason for Recall
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Distribution
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.
Lot / Code Info
Ref #537540, Lot #1003202200, Right Expiry date: 27-APR-2016
Root Cause
Labeling Change Control
Action Taken
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.