Recall Z-0749-2016— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2015-12-24, terminated 2017-12-04. It names one FDA 510(k) clearance: K993421. Product: BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).. Reason: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-24
- Terminated
- 2017-12-04
- 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¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
Reason for recall
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.