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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Legionella BCYE Growth Supplement

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  Class 2 Device Recall Oxoid Legionella BCYE Growth Supplement see related information
Date Initiated by Firm November 13, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on January 29, 2015
Recall Number Z-0578-2015
Recall Event ID 69771
510(K)Number K831469  
Product Classification Supplement, culture media - Product Code JSK
Product Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials.

A growth supplement for the isolation of Legionella.
Code Information Lot number: 1374439, Exp: 31 Aug 2015
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 could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
FDA Determined
Cause 2		 Under Investigation by firm
Action ThermoFisher sent an Urgent Medical Device Recall letter dated November 13, 2014, to the sole customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative identification of the affected product. Review their inventory for the affected product and discard it. Customers were also instructed to completed the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If further distributed customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730.
Quantity in Commerce 1/10/100 ml/vials/packs
Distribution Nationwide Distribution to FL
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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