FDA Medical Device Recalls (openFDA)
Remel Inc: 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.
- Recall number
- Z-0449-2015
- Recalling firm
- Remel Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-10-29
- Posted
- 2014-11-25
- Terminated
- 2015-06-01
- Reason
- The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
- Root cause
- Process control
- Action
- Thermo Fisher Scientific sent a Medical Device Recall letter dated October 29, 2014, to all affected customers. The letter notified customers that Remel, Inc., a part of Thermo Fisher Scientific, was voluntarily recalling the affected product. Customers were instructed to notify any personnel who need to be notified of the potential for false negative results. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.
- Quantity
- 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.
- Lot, serial or model codes
- Lot: 293086 Expiration 01Apr2015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTS
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28