Thermo Scientific QMS Everolimus Assay recall
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus…
Why was Thermo Scientific QMS Everolimus Assay 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.
- Product
- Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus…
- Recalling firm
- Microgenics Corporation
- 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.
- Recall date
- October 12, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)