Recall Z-0231-2015— Biomerieux
Class III · Terminated
Class III FDA medical device recall by Biomerieux, initiated 2014-10-16, terminated 2017-11-30. It names one FDA 510(k) clearance: K121002. Product: Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.. Reason: The products have a wrong expiration date on their labeling, 5 years instead of 2 years..
- Recalling firm
- Biomerieux
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-10-16
- Terminated
- 2017-11-30
- Firm location
- Letoile, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Reason for recall
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Data sourced from openFDA. This site is unofficial and independent of the FDA.