Recall Z-0801-2013— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2012-10-10, terminated 2013-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.. Reason: The product may contain low level microbial contamination which could result in incorrect results..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-10
- Terminated
- 2013-06-04
- Firm location
- Lenexa, KS, United States
Product description
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Reason for recall
The product may contain low level microbial contamination which could result in incorrect results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.