—#131196

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.

FDA product code: JTS — Stains, Microbiologic
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: Lot: 293086 Expiration 01Apr2015

Why it was recalled

The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-10-29
Posted by FDA: 2014-11-25
Terminated: 2015-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131196. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.