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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 Device Recall Legionella BCYE Growth Supplement SR0110Csee related information
Date Initiated by FirmOctober 10, 2012
Date PostedFebruary 11, 2013
Recall Status1 Terminated 3 on June 04, 2013
Recall NumberZ-0801-2013
Recall Event ID 63584
Product Classification Supplement, culture media - Product Code JSK
ProductThe 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
FEI Number 1924669
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactEarleen 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		Material/Component Contamination
ActionThermoFisher 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 Commerce10 units
DistributionDistribution included the states of IL, IN and MI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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