Remel Inc: Medical Device Recall in 2014 - (Recall #: Z-0449-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 29, 2014

Date Posted: December 3, 2014

Recall Number: Z-0449-2015

Event ID: 69629

Reason for Recall:

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

Status: Terminated

Product Quantity: 79/5/250- packages/bottles/ml

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.

Voluntary or Mandated:

Voluntary: Firm initiated