Thermo Scientific QMS Everolimus Assay — Class II medical device recall Z-0008-2017
Terminated recall by Microgenics Corporation, reported 2016-10-12, distributed nationwide. A reagent stability issue (still under investigation) causes less separation in the calibration curve, which a
| Recall number | Z-0008-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2016-08-15 |
| Classified | 2016-10-03 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-01-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, DE, DO, GT, MX, MY, PH, TW |
| Reason classes | potency, specification failure |
| Lot numbers | 72258007, 72258049 |
| Model numbers | 0380000 |
| Expiration dates | 2017-07-31 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0008-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.