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

FDA device recall Z-0449-2015 · posted 2014-11-25 · Terminated

Recall details

Recalling firm

Remel Inc

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

JTS

Quantity affected

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.

Date initiated

2014-10-29

Date posted

2014-11-25

Date terminated

2015-06-01

Location

Lenexa, KS