FDA Recall Terminated

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.

Recall: Z-0793-2014 · Initiated April 9, 2013

Recall

Recall Number
Z-0793-2014
Event Number
65184
Firm
Remel Inc
FEI Number
1924669
Product Code
JTN
Status
Terminated
Root Cause
Process design
Initiated
April 9, 2013
Posted
January 21, 2014
Terminated
January 21, 2014
Address
12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

Description

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.

Reason

Cartridges may contain individual discs which were not impregnated with antibiotic.

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.

Distribution

Nationwide Distribution: US including Puerto Rico.

Quantity

10 packs