PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 3, 2014 Initiated: October 29, 2014 #Z-0449-2015

Product 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.

Reason for Recall

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

Details

Recalling Firm
Remel Inc
Units Affected
79/5/250- packages/bottles/ml
Distribution
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.
Location
Lenexa, KS

Frequently Asked Questions

What product was recalled?
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.. Recalled by Remel Inc. Units affected: 79/5/250- packages/bottles/ml.
Why was this product recalled?
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0449-2015.