Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product

FDA device recall Z-0008-2017 · posted 2016-10-03 · Terminated

Recall details

Recalling firm

Microgenics Corporation

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

OUF

Quantity affected

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, Philippi

Date initiated

2016-08-15

Date posted

2016-10-03

Date terminated

2017-01-04

Location

Fremont, CA

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