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U.S. Department of Health and Human Services

Class 2 Device Recall Remel TB Potassium Permanganate

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  Class 2 Device Recall Remel TB Potassium Permanganate see related information
Date Initiated by Firm October 29, 2014
Date Posted November 25, 2014
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-0449-2015
Recall Event ID 69629
Product Classification Stains, microbiologic - Product Code JTS
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.
Code Information Lot: 293086 Expiration 01Apr2015
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Scott A. Kendall
913-888-0939
Manufacturer Reason
for Recall		 The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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