Oxoid 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.
FDA Recall Z-1246-2014 · Posted 2014-03-20
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTN
Date Initiated2014-02-18
Date Terminated2014-06-25
Product Quantity40/5/50-disc cartridge packages
Reason for Recall
Some of the discs may not be impregnated with the antibiotic.
Firm Action
ThermoFisher 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution
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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