Device 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.
Z-0801-2013
Product summary
- Firm
- Remel Inc
- Event
- Event 63584
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0801-2013
Official wording
Reason: The product may contain low level microbial contamination which could result in incorrect results.
Code information: Lot 1175209
Distribution pattern: Distribution included the states of IL, IN and MI.
Derived failure modes
-
Microbial contamination
microbial contamination