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.
Recall
- Recall Number
- Z-0449-2015
- Event Number
- 69629
- Firm
- Remel Inc
- FEI Number
- 1924669
- Product Code
- JTS
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 29, 2014
- Posted
- November 25, 2014
- Terminated
- June 1, 2015
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
Description
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.
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Thermo Fisher Scientific sent a Medical Device Recall letter dated October 29, 2014, to all affected customers. The letter notified customers that Remel, Inc., a part of Thermo Fisher Scientific, was voluntarily recalling the affected product. Customers were instructed to notify any personnel who need to be notified of the potential for false negative results. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.
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.
79/5/250- packages/bottles/ml