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Recall Observatory FDA recall evidence

Device product

Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. 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.

Z-1246-2014

February 18, 2014

Class II

Product summary

Firm
Remel Inc
Event
Event 67590
Status
Terminated
Classification
Class II
Quantity
40/5/50-disc cartridge packages
Official record key
device-enforcement:Z-1246-2014

Official wording

Reason: Some of the discs may not be impregnated with the antibiotic.

Code information: Lot 1174497, exp. 2015/04

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some of the discs may not be impregnated with the antibiotic.