Microgenics Corporation: Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

Recall number

Z-0415-2026

Recalling firm

Microgenics Corporation

Product

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

Status

Open, Classified

Initiated

2025-10-01

Posted

2025-10-30

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

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

Quantity

4462

Distribution

Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.

Lot, serial or model codes

OCRD-UL: UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30; OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30; OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30; OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30; OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30; OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30; OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJY

Firm FEI

3010939897

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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