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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Antimicrobial Susceptibility Discs Amoxycillin Clavulanic Acid

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 Class 2 Device Recall Oxoid Antimicrobial Susceptibility Discs Amoxycillin Clavulanic Acidsee related information
Date Initiated by FirmJune 18, 2021
Create DateJuly 26, 2021
Recall Status1 Terminated 3 on August 04, 2023
Recall NumberZ-2142-2021
Recall Event ID 88205
510(K)NumberK982524 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Code Information Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactTechnical Services Department
800-255-6730
Manufacturer Reason
for Recall		Out of Specification
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn June 18, 2021 the firm sent letter to their consignees with the following info; To destroy any remaining inventory of the lot listed above and contact Technical Services regarding any necessary replacements. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
Quantity in Commerce327 units
DistributionWorldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. The countries of BERMUDA.
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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