FDA Medical Device Recalls (openFDA)
Biomerieux: 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.
- Recall number
- Z-0230-2015
- Recalling firm
- Biomerieux
- 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.
- Status
- Terminated
- Initiated
- 2014-10-16
- Posted
- 2014-11-19
- Terminated
- 2017-11-30
- Reason
- The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
- Root cause
- Labeling Change Control
- 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.
- Quantity
- 652 devices
- 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, serial or model codes
- Ref #537500, Lot #1003160540, Right Expiry date: 27-APR-2016
- 510(k) numbers
- ["K121002"]
- PMA numbers
- not on file
- Product code
- JWY
- Firm FEI
- 1000611339
- Firm city
- Letoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28