Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
FDA Recall Z-2081-2013 · Posted 2013-08-26
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJTN
Date Initiated2013-03-25
Date Terminated2014-06-03
Product Quantity60 packs
Reason for Recall
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Firm Action
ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product.
If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
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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