Class III — Biomerieux
| Recalling firm | BIOMERIEUX SA |
|---|---|
| Registered facility | View this company's 16 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. |
| Product | Etest® Ceftaroline (CPT32) US B100. Etest® (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. |
| 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 Urugu… |
| Initiated | 2014-10-16 |
| Classified | 2014-11-19 |
| Terminated | 2017-11-30 |
| Recall number | Z-0233-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Biomerieux (Z-0233-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69579/
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