Recall Z-0449-2015— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2014-10-29, terminated 2015-06-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-29
- Terminated
- 2015-06-01
- Firm location
- Lenexa, KS, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.