FDA-Device2013-02-20Class II

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.

Remel Inc
Hazard

The product may contain low level microbial contamination which could result in incorrect results.

Sold states
Distribution included the states of IL, IN and MI.
Affected count
10 units
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2013

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