Oxoid 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.
FDA Recall Z-0443-2016 · Posted None
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTN
Date Initiated2015-11-06
Date Terminated2017-02-13
Product Quantity58/5/50 discs/catridges/packs
Reason for Recall
Antibiotic concentration may be insufficient which may result in incorrect test results.
Firm Action
ThermoFisher 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA. Product was also distributed to Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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