Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. 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 to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Recall Z-0793-2014 · Posted 2014-01-21
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTN
Date Initiated2013-04-09
Date Terminated2014-01-21
Product Quantity10 packs
Reason for Recall
Cartridges may contain individual discs which were not impregnated with antibiotic.
Firm Action
ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International).
For questions regarding this recall call 913-895-4185.
Root Cause
Process design
Distribution Pattern
Nationwide Distribution: US including 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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