FDA Recall Terminated

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.

Recall: Z-2081-2013 · Initiated March 25, 2013

Recall

Recall Number
Z-2081-2013
Event Number
64852
Firm
Remel Inc
FEI Number
1924669
Product Code
JTN
Status
Terminated
Root Cause
Unknown/Undetermined by firm
Initiated
March 25, 2013
Posted
August 26, 2013
Terminated
June 3, 2014
Address
12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

Description

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.

Reason

Use of affected lots may give false indication of susceptibility to Nitrofurantoin.

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).

Distribution

US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.

Quantity

60 packs