Z-0449-2015Class II

Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in...

Name: Z-0449-2015 Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in...
Creator: Remel Inc
Published: 2014-10-29
License: https://open.fda.gov/license/

Remel Inc / initiated 2014-10-29 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of 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... on 2014-10-29. FDA classified it as Class II and gives the reason as "The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0449-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-29
Posted: 2014-11-25
Terminated: 2015-06-01
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.
Product code: JTS Stains, Microbiologic
Reason for recall: The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot: 293086 Expiration 01Apr2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0449-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0449-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-24

Product code JTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)