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