Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue
Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where inaccurate results could affect patient management, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay, an in vitro diagnostic device used to measure Everolimus levels in human whole blood. The recall affects 163 kits in the United States and 669 kits worldwide, totaling 831 kits. The affected lots are 72258049 and 72258007, both with an expiry date of 07/31/2017.
The recall was initiated due to a reagent stability issue that is still under investigation. This issue causes less separation in the calibration curve, which affects results across the entire measuring range. For controls, maximum bias ranges from +/- 33% to +/- 47% depending on the level. In patient samples, bias ranges from -15.7% to +5.2% with an average of -5.6% when compared to a reference method.
The QMS Everolimus Assay is intended for clinical laboratory use only to aid in the management of kidney and liver transplant patients receiving Everolimus therapy. Patient samples in sub-therapeutic, therapeutic, and supra-therapeutic ranges could be affected by the bias. The product was distributed in the US and in countries including Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, and Australia.
The recalled product
- 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 analyz
- Manufacturer
- Microgenics Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot number: 72258049
- Expiry date: 07/31/2017
- Lot number: 72258007
- Expiry date 07/31/2017.
Distribution
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