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Class 2 Device Recall Remel TB Potassium Permanganate |
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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
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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
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For Additional Information Contact |
Scott A. Kendall 913-888-0939
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Manufacturer Reason for Recall |
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
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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
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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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