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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 SR0110A see related information
Date Initiated by Firm February 05, 2015
Date Posted March 02, 2015
Recall Status1 Terminated 3 on February 13, 2017
Recall Number Z-1232-2015
Recall Event ID 70471
510(K)Number K831469  
Product Classification Supplement, culture media - Product Code JSK
Product Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
Code Information Lot No. 1545171 
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Scott A. Kendall
770-409-0713
Manufacturer Reason
for Recall		 Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
FDA Determined
Cause 2		 Under Investigation by firm
Action ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review all results reported using the recalled lot. The recalling firm requested the consignees complete and return the Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. If the affected lot was further distributed, the consignees were instructed to notify those entities of the recall and provide a copy of the recall notification letter. If you have any questions, please contact our Technical Services Department at 800.255.6730 (US) or 913.888.0939 ( International)
Quantity in Commerce 24 packs (10 x 100 ml vials)
Distribution US Distribution to the states of : MI, ND, SC, TN, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JSK and Original Applicant = OXOID U.S.A., INC.
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