Etest Ceftaroline (CPT32) US B100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determin
FDA device recall Z-0233-2015 · posted 2014-11-19 · Terminated
Recall details
- Recalling firm
- Biomerieux
- Reason for recall
- The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- 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 countr
- Date initiated
- 2014-10-16
- Date posted
- 2014-11-19
- Date terminated
- 2017-11-30
- Location
- Letoile, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ETEST CEFTAROLINE (K121002) | bioMerieux, Inc. | 2012-10-12 |