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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 FirmJanuary 24, 2014
Date PostedFebruary 26, 2014
Recall Status1 Terminated 3 on July 23, 2014
Recall NumberZ-1112-2014
Recall Event ID 67415
510(K)NumberK831469 
Product Classification Supplement, culture media - Product Code JSK
ProductOxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.
Code Information Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactEarleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		The product may contain high levels of microbial contamination
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionThermo Fisher sent an Urgent Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please notify any personnel who need to be aware of the potential for false presumptive Legionella spp. identification or masking of the recovery/isolation of Legionella spp. Review your inventory for the affected product and discard it. You should review results reported using these lots and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If you have further distributed these product lots, please contact those entities, advise them of the situation and provide them with a copy of this letter. You should insert your contact information, email, and fax numbers in the acknowledgement form and request that they return it to you. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce44/10/500-ml. vial boxes
DistributionUS Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
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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