Recall Z-0738-2013— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2012-12-25, terminated 2014-06-03. It names one FDA 510(k) clearance: K020931. Product: BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.. Reason: BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-25
- Terminated
- 2014-06-03
- Firm location
- Durham, NC, United States
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
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Reason for recall
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.