FDA Device recall Z-0449-2015
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg by Remel, citing the product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0449-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-29 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | AL, CA, CO, IA, MO, NC, NV, NY, OH, PA, SC, SD, TN, TX, VA, WI |
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.
Identifiers
| code_info | Lot: 293086 Expiration 01Apr2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0449-2015%22
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