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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Legionella BCYE Growth Supplement SR0110C		see related information
Date Posted February 11, 2013
Recall Number Z-0801-2013
Product The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCVE Medium used for isolation of Legionellae from clinical and environmental samples.
Code Information Lot 1175209
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa, Kansas 66215-3519
For Additional Information Contact Earleen C. Parks
913-888-0939
Reason for
Recall		 The product may contain low level microbial contamination which could result in incorrect results.
Action ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization. The firm request the information form be faxed back confirming receipt of notice. For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.
Quantity in Commerce 10 units
Distribution Nationwide Distribution including the states of IL, IN and MI.
 
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