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U.S. Department of Health and Human Services

Class 2 Device Recall QMS Everolimus Assay

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  Class 2 Device Recall QMS Everolimus Assay see related information
Date Initiated by Firm August 15, 2016
Date Posted October 03, 2016
Recall Status1 Terminated 3 on January 04, 2017
Recall Number Z-0008-2017
Recall Event ID 74982
510(K)Number K122766  
Product Classification Everolimus immunoassay - Product Code OUF
Product Thermo Scientific QMS Everolimus Assay;
Model number:
0380000 (US Distribution);
0373852 (Foreign Distribution)

Product Usage:
The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
Code Information Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.
Recalling Firm/
Manufacturer		 Microgenics Corporation
46500 Kato Rd
Fremont CA 94538-7310
For Additional Information Contact Jeffrey J/ Fisher
510-979-5000
Manufacturer Reason
for Recall		 A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range  sub-therapeutic, therapeutic, and supra-therapeutic  could be affected.
FDA Determined
Cause 2		 Under Investigation by firm
Action Thermo Fisher sent an Urgent Medical Device Field Action letter dated on August 15, 2016 to customers via regular mail. The letter identified the affected product, problem and actions to be taken. Customers are advised to Discontinue use and destroy any remaining inventory of the affected lots per your local waste ordinances. Customers were instructed to cmplete the attached Medical Device Field Action Response Form and return the form to Thermo Fisher Scientific Technical Service. For questions contact Technical Service at 1-800-232-3342 (USA only) or 510-979-5000 (outside the USA) then press option 2, then option 3.
Quantity in Commerce 163 kits in US, 669 kits worldwide - toatal 831.
Distribution Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.
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.
510(K) Database 510(K)s with Product Code = OUF and Original Applicant = MICROGENICS CORP.
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