Device product
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.
Z-0234-2015
Product summary
- Firm
- Biomerieux
- Event
- Event 69579
- Status
- Terminated
- Classification
- Class III
- Quantity
- 652 devices
- Official record key
device-enforcement:Z-0234-2015
Official wording
Reason: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Code information: Ref #537540, Lot #1003301830, Right Expiry date: 30-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
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.