—#119988

Product

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.

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K860153
Affected lot / code info: Lot number: 1220205, exp July 21, 2015

Why it was recalled

Boxes labeled as CIP5 may contain cartridges of AMP5.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-11-21
Posted by FDA: 2013-12-17
Terminated: 2014-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.