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Recall Observatory FDA recall evidence

Device 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.

Z-0528-2014

November 21, 2012

Class III

Product summary

Firm
Remel Inc
Event
Event 65734
Status
Terminated
Classification
Class III
Quantity
60/5/50-disc cartridge boxes
Official record key
device-enforcement:Z-0528-2014

Official wording

Reason: Boxes labeled as CIP5 may contain cartridges of AMP5.

Code information: Lot number: 1220205, exp July 21, 2015

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boxes labeled as CIP5 may contain cartridges of AMP5.