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Recall Observatory FDA recall evidence

Device product

Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

Z-0449-2015

October 29, 2014

Class II

Product summary

Firm
Remel Inc
Event
Event 69629
Status
Terminated
Classification
Class II
Quantity
79/5/250- packages/bottles/ml
Official record key
device-enforcement:Z-0449-2015

Official wording

Reason: The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

Code information: Lot: 293086 Expiration 01Apr2015

Distribution pattern: Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.