Microgenics Corporation recalls Thermo scientific MAS Omni CARDIO

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

ThermoFisher Scientific issued an URGENT -MEDICAL DEVICE RECALL notice to its consignees on 10/02/2025 via email. The notice explained the issue, risk to health, and requested the following: "ACTIONS TO BE TAKEN BY A USER 1. If you are a user of the High sensitivity Troponin I Assay, determine if you have inventory of the affected lots of MAS Omni"CARDIO" control as listed in Table 1. As stated in the instructions for use, instrument values provided are specific to this lot of control only and are intended to assist the laboratory in establishing its own means and ranges. 2. You may continue to use controls that meet your laboratory s performance requirements. 3. If the variability of the material exceeds your laboratory s specification, dispose of the material in accordance with local, regional, and national regulations. After disposing of the material, contact TechService.mgc@thermofisher.com for a credit. 4. Customers using the affected product with standard/ regular Troponin I assays, can continue to use the product as long as it meets their laboratory s specification and continue monitoring performance of Troponin I in MAS Omni"CARDIO" control. 5. This recall notice needs to be passed to anyone within your organization or any organization where the potentially affected lots have been transferred. 6. Retain a copy of this letter for your laboratory records. 7. Please complete the Recall Response Form attached to this Notification within 10 days of the date of this letter and return to Thermo Fisher as instructed in the form to E-mail:MGCFSCA@thermofisher.com 8. If you have any additional questions regarding this Recall Notice, contact Thermo Fisher Scientific Technical Support at toll free 1-800-232-3342 (USA and Canada only) or 510-979-5000 (International), Option 2, then option 3 or by email: TechService.mgc@thermofisher.com." "ACTIONS TO BE TAKEN BY A DISTRIBUTOR 1. Please notify your customers of this Recall Notice using this recall notice and request t

• FDA enforcement recordOfficial FDA database entry for Z-0415-2026
• FDA device classification · JJYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Microgenics CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.