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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Vancomycin susceptibility discs, 30 mcg.

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 Class 2 Device Recall Oxoid Vancomycin susceptibility discs, 30 mcg.see related information
Date Initiated by FirmFebruary 18, 2014
Date PostedMarch 20, 2014
Recall Status1 Terminated 3 on June 25, 2014
Recall NumberZ-1246-2014
Recall Event ID 67590
510(K)NumberK860153 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductOxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Code Information Lot 1174497, exp. 2015/04
FEI Number 1924669
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		Some of the discs may not be impregnated with the antibiotic.
FDA Determined
Cause 2		Process control
ActionThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. 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 notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot 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 product was 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 the Technical Services Department at 800-255-6730 (US) and 913-888-0939 (International). For questions regarding this recal lcall 913-895-4185.
Quantity in Commerce40/5/50-disc cartridge packages
DistributionNationwide Distribution
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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