Remel TB Potassium Permanganate — Class II medical device recall Z-0449-2015
Terminated recall by Remel Inc, reported 2014-12-03, distributed in AL, CA, CO, IA, MO, NC, NV, NY…. The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobact
| Recall number | Z-0449-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2014-10-29 |
| Classified | 2014-11-24 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-06-01 |
| Distributed | AL, CA, CO, IA, MO, NC, NV, NY, OH, PA, SC, SD, TN, TX, VA, WI |
| Countries outside the US | CA |
| Lot numbers | 293086 |
| Expiration dates | 2015-04-01 |
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 for recall
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0449-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.