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U.S. Department of Health and Human Services

Class 2 Device Recall Legionella BCYE Growth Supplement SR0110C

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 Class 2 Recall
Legionella BCYE Growth Supplement SR0110C
see related information
Date Posted February 11, 2013
Recall Status1 Terminated on June 04, 2013
Recall Number Z-0801-2013
Recall Event ID 63584
Product Classification Supplement, Culture Media - Product Code JSK
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.
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
Manufacturer Reason
for Recall
The product may contain low level microbial contamination which could result in incorrect results.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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 Distribution included the states of IL, IN and MI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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