[pending] Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-0415-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- Microgenics Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- OCRD-UL: UDI/DI 00884883011946
- Lot Number OCRD2704U
- Exp 2027-04-30
- OCRD-L: UDI/DI 00884883011953
- Lot Number OCRD2704L
- OCRD-101: UDI/DI 00884883011960
- Lot Number OCRD27041
- OCRD-202: UDI/DI 00884883011977
- Lot Number OCRD27042
- OCRD-303: UDI/DI 00884883011984
- Lot Number OCRD27043
- OCRD-SP: UDI/DI 00884883011991
- Lot Number OCRD2704S
- OCRD-MP: UDI/DI 00884883012004
- Lot Number OCRD2704M
- Exp 2027-04-30.
Distribution
Distributed nationwide across the United States.
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