Microgenics Corporation: 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.

Recall number

Z-0008-2017

Recalling firm

Microgenics Corporation

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.

Status

Terminated

Initiated

2016-08-15

Posted

2016-10-03

Terminated

2017-01-04

Reason

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.

Root cause

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

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.

Lot, serial or model codes

Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.

510(k) numbers

["K122766"]

PMA numbers

not on file

Product code

OUF

Firm FEI

3010939897

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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