Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 12, 2016
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 E
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 o…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microgenics Corporation recalled Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 03738… - a moderate-severity action.
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 03738… was recalled by Microgenics Corporation in October 12, 2016. Reason: A reagent stability issue (still under investigation) causes less separation in the calibration curve, which …. Check the official notice for the remedy. Verify recall #Z-0008-2017 with the FDA Devices before acting.
The recall
Microgenics Corporation issued this moderate-severity FDA Devices recall-A reagent stability issue (still under investigation) causes less separation in the calibration curve, which ….
- Moderate
- severity level
- Class II
- classification
- October 12, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0008-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0008-2017) was formally reported on October 12, 2016, with the manufacturer initiating the action on August 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Microgenics Corporation is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as 163 kits in US, 669 kits worldwide - toatal 831..
The documented reason for this recall is: 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 mi… Distribution data in the federal record shows the product reached: 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, Austr…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
163 kits in US, 669 kits worldwide - toatal 831.
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0008-2017 |
| Date reported | October 12, 2016 |
| Date initiated | August 15, 2016 |
| Recalling firm | Microgenics Corporation |
| Firm location | Fremont, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0008-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microgenics Corporation. Units affected: 163 kits in US, 669 kits worldwide - toatal 831..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2016. Severity: Moderate. Recall number: Z-0008-2017.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0008-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 12, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.