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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Gentamicin Anticrobial Susceptibility Testing Disc

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 Class 2 Device Recall Oxoid Gentamicin Anticrobial Susceptibility Testing Discsee related information
Date Initiated by FirmNovember 06, 2015
Create DateDecember 17, 2015
Recall Status1 Terminated 3 on February 13, 2017
Recall NumberZ-0443-2016
Recall Event ID 72525
510(K)NumberK860153 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductOxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Code Information Lot 1686823, expiry 30 June 2018
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactGary L. Klaassen
913-895-4077
Manufacturer Reason
for Recall		Antibiotic concentration may be insufficient which may result in incorrect test results.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThermoFisher Scientific sent an Urgent Medical Device Recall letter dated November 6, 2015, to all affected customers via first class mail. The recall notice identified the problem with the device and asked customers to inspect their stocks for the affected lots. The notice instructed customers to destroy any remaining inventory from the affected lots, contact the recalling firm for replacement, and complete the accompanying Acknowledgement form. Customers with questions were instructed to contact the Technical Services Departmentn at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-895-4077.
Quantity in Commerce58/5/50 discs/catridges/packs
DistributionNationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.
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 = JTN
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