FDA Recall Terminated

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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-0528-2014 · Initiated November 21, 2012

Recall

Recall Number
Z-0528-2014
Event Number
65734
Firm
Remel Inc
FEI Number
1924669
Product Code
JTN
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
November 21, 2012
Posted
December 17, 2013
Terminated
March 12, 2014
Address
12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

Description

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. 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

Boxes labeled as CIP5 may contain cartridges of AMP5.

Action

Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any product labeled AMP5. For questions regarding this recall call 913-895-4185.

Distribution

Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.

Quantity

60/5/50-disc cartridge boxes