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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Legionella BCYE Growth Supplement SR0110A

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 Class 2 Device Recall Oxoid Legionella BCYE Growth Supplement SR0110Asee related information
Date Initiated by FirmOctober 17, 2014
Date PostedNovember 10, 2014
Recall Status1 Terminated 3 on February 13, 2017
Recall NumberZ-0200-2015
Recall Event ID 69521
510(K)NumberK831469 
Product Classification Supplement, culture media - Product Code JSK
ProductOxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
Code Information Lot Number: 1451506 Expiration: 26Feb2016
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactScott A. Kendall
770-409-0713
Manufacturer Reason
for Recall		Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
FDA Determined
Cause 2		Under Investigation by firm
ActionThermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.
Quantity in Commerce16/10/100 ml, vial, pkgs
DistributionDistributed in the states of ND, VT and TX.
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.
510(K) Database510(K)s with Product Code = JSK
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