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U.S. Department of Health and Human Services

Class 3 Device Recall Oxoid Antimicrobial Susceptability Testing Discs F300 (Nitrofurantoin)

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  Class 3 Device Recall Oxoid Antimicrobial Susceptability Testing Discs F300 (Nitrofurantoin) see related information
Date Initiated by Firm March 25, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on June 03, 2014
Recall Number Z-2081-2013
Recall Event ID 64852
510(K)Number K860153  
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
Product Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England

Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Code Information Lots 1194944 and 1198342
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Earleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		 Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).
Quantity in Commerce 60 packs
Distribution US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
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 = JTN and Original Applicant = OXOID U.S.A., INC.
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